Hikma Pharmaceuticals RX
FDA Approved Drugs
Hikma Pharmaceuticals RX
FDA Approved Drugs Database
FDA approved drug product records including application numbers, product numbers, drug names, active ingredients, dosage forms, strengths, approval dates and regulatory status.
- Total Records 585
- Latest Approval Date Jul 28, 2026
- Data Source FDA
- First Approval Date Jan 01, 1982
Company Overview
Company
Hikma Pharmaceuticals RX
Country
United Kingdom
Website
Social Profiles
Company Snapshot
Hikma Pharmaceuticals RX
1 New Burlington Place, Mayfair, London, W1S 2HR
United Kingdom
www.hikma.com/home/ Sarrar@hikma.com View on MapFDA Approved Drug Records ( 585 records )
Drug Name
ABIRATERONE ACETATE
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2018-10-31
Active Ingredient
ABIRATERONE ACETATE
Application Number
208339
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2018-10-31
Regulatory Status
RX
Drug Name
ACARBOSE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2008-05-07
Active Ingredient
ACARBOSE
Application Number
78470
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2008-05-07
Regulatory Status
RX
Drug Name
ACARBOSE
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2008-05-07
Active Ingredient
ACARBOSE
Application Number
78470
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2008-05-07
Regulatory Status
RX
Drug Name
ACARBOSE
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2008-05-07
Active Ingredient
ACARBOSE
Application Number
78470
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2008-05-07
Regulatory Status
RX
Drug Name
ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
1GM/100ML (10MG/ML)
Approval Date
2016-06-13
Active Ingredient
ACETAMINOPHEN
Application Number
202605
Product Number
1
Dosage Form
-
Strength
1GM/100ML (10MG/ML)
Approval Date
2016-06-13
Regulatory Status
RX
Drug Name
ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
1GM/100ML (10MG/ML)
Approval Date
2022-06-03
Active Ingredient
ACETAMINOPHEN
Application Number
206968
Product Number
1
Dosage Form
-
Strength
1GM/100ML (10MG/ML)
Approval Date
2022-06-03
Regulatory Status
RX
Drug Name
ACETAZOLAMIDE SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
1995-02-28
Active Ingredient
ACETAZOLAMIDE SODIUM
Application Number
40089
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
1995-02-28
Regulatory Status
RX
Drug Name
ADENOSINE
Product Number
1
Dosage Form
-
Strength
3MG/ML
Approval Date
2004-06-16
Active Ingredient
ADENOSINE
Application Number
76404
Product Number
1
Dosage Form
-
Strength
3MG/ML
Approval Date
2004-06-16
Regulatory Status
RX
Drug Name
ADENOSINE
Product Number
1
Dosage Form
-
Strength
3MG/ML
Approval Date
2004-06-16
Active Ingredient
ADENOSINE
Application Number
76500
Product Number
1
Dosage Form
-
Strength
3MG/ML
Approval Date
2004-06-16
Regulatory Status
RX
Drug Name
ALENDRONATE SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 70MG BASE/75ML
Approval Date
2013-02-25
Active Ingredient
ALENDRONATE SODIUM
Application Number
90520
Product Number
1
Dosage Form
-
Strength
EQ 70MG BASE/75ML
Approval Date
2013-02-25
Regulatory Status
RX
Drug Name
ALLOPURINOL SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2004-08-26
Active Ingredient
ALLOPURINOL SODIUM
Application Number
76870
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2004-08-26
Regulatory Status
RX
Drug Name
ALPRAZOLAM
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
1993-10-31
Active Ingredient
ALPRAZOLAM
Application Number
74312
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
1993-10-31
Regulatory Status
RX
Drug Name
ALPROSTADIL
Product Number
1
Dosage Form
-
Strength
0.5MG/ML
Approval Date
1998-01-20
Active Ingredient
ALPROSTADIL
Application Number
74815
Product Number
1
Dosage Form
-
Strength
0.5MG/ML
Approval Date
1998-01-20
Regulatory Status
RX
Drug Name
ALVIMOPAN
Product Number
1
Dosage Form
-
Strength
12MG
Approval Date
2023-08-31
Active Ingredient
ALVIMOPAN
Application Number
217753
Product Number
1
Dosage Form
-
Strength
12MG
Approval Date
2023-08-31
Regulatory Status
RX
Drug Name
AMICAR
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
1982-01-01
Active Ingredient
AMINOCAPROIC ACID
Application Number
15197
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
AMICAR
Product Number
2
Dosage Form
-
Strength
1GM
Approval Date
2004-06-24
Active Ingredient
AMINOCAPROIC ACID
Application Number
15197
Product Number
2
Dosage Form
-
Strength
1GM
Approval Date
2004-06-24
Regulatory Status
RX
Drug Name
AMICAR
Product Number
2
Dosage Form
-
Strength
0.25GM/ML
Approval Date
1982-01-01
Active Ingredient
AMINOCAPROIC ACID
Application Number
15230
Product Number
2
Dosage Form
-
Strength
0.25GM/ML
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
AMIKACIN SULFATE
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/ML
Approval Date
1994-04-11
Active Ingredient
AMIKACIN SULFATE
Application Number
63313
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/ML
Approval Date
1994-04-11
Regulatory Status
RX
Drug Name
AMIKACIN SULFATE
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE/ML
Approval Date
1994-04-11
Active Ingredient
AMIKACIN SULFATE
Application Number
63315
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE/ML
Approval Date
1994-04-11
Regulatory Status
RX
Drug Name
AMIODARONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
50MG/ML
Approval Date
2008-02-25
Active Ingredient
AMIODARONE HYDROCHLORIDE
Application Number
77234
Product Number
1
Dosage Form
-
Strength
50MG/ML
Approval Date
2008-02-25
Regulatory Status
RX
Drug Name
AMOXICILLIN
Product Number
1
Dosage Form
-
Strength
875MG
Approval Date
2006-03-29
Active Ingredient
AMOXICILLIN
Application Number
65255
Product Number
1
Dosage Form
-
Strength
875MG
Approval Date
2006-03-29
Regulatory Status
RX
Drug Name
AMOXICILLIN
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2007-02-05
Active Ingredient
AMOXICILLIN
Application Number
65291
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2007-02-05
Regulatory Status
RX
Drug Name
AMOXICILLIN
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2007-02-05
Active Ingredient
AMOXICILLIN
Application Number
65291
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2007-02-05
Regulatory Status
RX
Drug Name
AMOXICILLIN
Product Number
1
Dosage Form
-
Strength
250MG/5ML
Approval Date
2006-06-19
Active Ingredient
AMOXICILLIN
Application Number
65322
Product Number
1
Dosage Form
-
Strength
250MG/5ML
Approval Date
2006-06-19
Regulatory Status
RX
Drug Name
AMOXICILLIN
Product Number
2
Dosage Form
-
Strength
125MG/5ML
Approval Date
2006-06-19
Active Ingredient
AMOXICILLIN
Application Number
65322
Product Number
2
Dosage Form
-
Strength
125MG/5ML
Approval Date
2006-06-19
Regulatory Status
RX
Drug Name
AMOXICILLIN
Product Number
1
Dosage Form
-
Strength
400MG/5ML
Approval Date
2006-06-19
Active Ingredient
AMOXICILLIN
Application Number
65325
Product Number
1
Dosage Form
-
Strength
400MG/5ML
Approval Date
2006-06-19
Regulatory Status
RX
Drug Name
AMOXICILLIN
Product Number
2
Dosage Form
-
Strength
200MG/5ML
Approval Date
2006-06-19
Active Ingredient
AMOXICILLIN
Application Number
65325
Product Number
2
Dosage Form
-
Strength
200MG/5ML
Approval Date
2006-06-19
Regulatory Status
RX
Drug Name
AMOXICILLIN AND CLAVULANATE POTASSIUM
Product Number
1
Dosage Form
-
Strength
400MG/5ML;EQ 57MG BASE/5ML
Approval Date
2005-01-25
Active Ingredient
AMOXICILLIN; CLAVULANATE POTASSIUM
Application Number
65191
Product Number
1
Dosage Form
-
Strength
400MG/5ML;EQ 57MG BASE/5ML
Approval Date
2005-01-25
Regulatory Status
RX
Drug Name
AMOXICILLIN AND CLAVULANATE POTASSIUM
Product Number
2
Dosage Form
-
Strength
200MG/5ML;EQ 28.5MG BASE/5ML
Approval Date
2005-01-25
Active Ingredient
AMOXICILLIN; CLAVULANATE POTASSIUM
Application Number
65191
Product Number
2
Dosage Form
-
Strength
200MG/5ML;EQ 28.5MG BASE/5ML
Approval Date
2005-01-25
Regulatory Status
RX
Drug Name
AMOXICILLIN AND CLAVULANATE POTASSIUM
Product Number
1
Dosage Form
-
Strength
600MG/5ML;EQ 42.9MG BASE/5ML
Approval Date
2007-11-09
Active Ingredient
AMOXICILLIN; CLAVULANATE POTASSIUM
Application Number
65373
Product Number
1
Dosage Form
-
Strength
600MG/5ML;EQ 42.9MG BASE/5ML
Approval Date
2007-11-09
Regulatory Status
RX
Drug Name
AMOXICILLIN AND CLAVULANATE POTASSIUM
Product Number
1
Dosage Form
-
Strength
875MG;EQ 125MG BASE
Approval Date
2016-08-23
Active Ingredient
AMOXICILLIN; CLAVULANATE POTASSIUM
Application Number
203824
Product Number
1
Dosage Form
-
Strength
875MG;EQ 125MG BASE
Approval Date
2016-08-23
Regulatory Status
RX
Drug Name
AMPICILLIN AND SULBACTAM
Product Number
1
Dosage Form
-
Strength
EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL
Approval Date
2002-03-19
Active Ingredient
AMPICILLIN SODIUM; SULBACTAM SODIUM
Application Number
65076
Product Number
1
Dosage Form
-
Strength
EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL
Approval Date
2002-03-19
Regulatory Status
RX
Drug Name
AMRINONE LACTATE
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/ML
Approval Date
2000-05-09
Active Ingredient
INAMRINONE LACTATE
Application Number
75513
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/ML
Approval Date
2000-05-09
Regulatory Status
RX
Drug Name
ARGATROBAN
Product Number
1
Dosage Form
-
Strength
250MG/2.5ML (100MG/ML)
Approval Date
2012-01-05
Active Ingredient
ARGATROBAN
Application Number
203049
Product Number
1
Dosage Form
-
Strength
250MG/2.5ML (100MG/ML)
Approval Date
2012-01-05
Regulatory Status
RX
Drug Name
ARGATROBAN
Product Number
2
Dosage Form
-
Strength
50MG/50ML (1MG/ML)
Approval Date
2016-09-30
Active Ingredient
ARGATROBAN
Application Number
203049
Product Number
2
Dosage Form
-
Strength
50MG/50ML (1MG/ML)
Approval Date
2016-09-30
Regulatory Status
RX
Drug Name
ATIVAN
Product Number
1
Dosage Form
-
Strength
2MG/ML
Approval Date
1982-01-01
Active Ingredient
LORAZEPAM
Application Number
18140
Product Number
1
Dosage Form
-
Strength
2MG/ML
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
ATIVAN
Product Number
2
Dosage Form
-
Strength
4MG/ML
Approval Date
1982-01-01
Active Ingredient
LORAZEPAM
Application Number
18140
Product Number
2
Dosage Form
-
Strength
4MG/ML
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
ATRACURIUM BESYLATE
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
1997-07-18
Active Ingredient
ATRACURIUM BESYLATE
Application Number
74901
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
1997-07-18
Regulatory Status
RX
Drug Name
ATRACURIUM BESYLATE PRESERVATIVE FREE
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
1997-07-18
Active Ingredient
ATRACURIUM BESYLATE
Application Number
74900
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
1997-07-18
Regulatory Status
RX
Drug Name
ATROPINE SULFATE
Product Number
1
Dosage Form
-
Strength
8MG/20ML (0.4MG/ML)
Approval Date
2021-12-01
Active Ingredient
ATROPINE SULFATE
Application Number
213561
Product Number
1
Dosage Form
-
Strength
8MG/20ML (0.4MG/ML)
Approval Date
2021-12-01
Regulatory Status
RX
Drug Name
ATROPINE SULFATE
Product Number
1
Dosage Form
-
Strength
0.4MG/ML (0.4MG/ML)
Approval Date
2025-10-24
Active Ingredient
ATROPINE SULFATE
Application Number
217345
Product Number
1
Dosage Form
-
Strength
0.4MG/ML (0.4MG/ML)
Approval Date
2025-10-24
Regulatory Status
RX
Drug Name
ATROPINE SULFATE
Product Number
2
Dosage Form
-
Strength
1MG/ML (1MG/ML)
Approval Date
2025-10-24
Active Ingredient
ATROPINE SULFATE
Application Number
217345
Product Number
2
Dosage Form
-
Strength
1MG/ML (1MG/ML)
Approval Date
2025-10-24
Regulatory Status
RX
Drug Name
AZACITIDINE
Product Number
1
Dosage Form
-
Strength
100MG/VIAL
Approval Date
2020-06-08
Active Ingredient
AZACITIDINE
Application Number
209337
Product Number
1
Dosage Form
-
Strength
100MG/VIAL
Approval Date
2020-06-08
Regulatory Status
RX
Drug Name
AZATHIOPRINE SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE/VIAL
Approval Date
1995-03-31
Active Ingredient
AZATHIOPRINE SODIUM
Application Number
74419
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE/VIAL
Approval Date
1995-03-31
Regulatory Status
RX
Drug Name
BALSALAZIDE DISODIUM
Product Number
1
Dosage Form
-
Strength
750MG
Approval Date
2007-12-28
Active Ingredient
BALSALAZIDE DISODIUM
Application Number
77806
Product Number
1
Dosage Form
-
Strength
750MG
Approval Date
2007-12-28
Regulatory Status
RX
Drug Name
BENZTROPINE MESYLATE
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2009-08-31
Active Ingredient
BENZTROPINE MESYLATE
Application Number
90287
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2009-08-31
Regulatory Status
RX
Drug Name
BENZTROPINE MESYLATE
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2021-10-14
Active Ingredient
BENZTROPINE MESYLATE
Application Number
209442
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2021-10-14
Regulatory Status
RX
Drug Name
BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE
Product Number
1
Dosage Form
-
Strength
3MG/ML;EQ 3MG BASE/ML
Approval Date
2023-01-17
Active Ingredient
BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE
Application Number
77838
Product Number
1
Dosage Form
-
Strength
3MG/ML;EQ 3MG BASE/ML
Approval Date
2023-01-17
Regulatory Status
RX
Drug Name
BEXAROTENE
Product Number
1
Dosage Form
-
Strength
75MG
Approval Date
2020-06-16
Active Ingredient
BEXAROTENE
Application Number
203663
Product Number
1
Dosage Form
-
Strength
75MG
Approval Date
2020-06-16
Regulatory Status
RX
Drug Name
BLEOMYCIN SULFATE
Product Number
1
Dosage Form
-
Strength
EQ 30 UNITS BASE/VIAL
Approval Date
2001-10-17
Active Ingredient
BLEOMYCIN SULFATE
Application Number
65042
Product Number
1
Dosage Form
-
Strength
EQ 30 UNITS BASE/VIAL
Approval Date
2001-10-17
Regulatory Status
RX
Drug Name
BLEOMYCIN SULFATE
Product Number
2
Dosage Form
-
Strength
EQ 15 UNITS BASE/VIAL
Approval Date
2001-10-17
Active Ingredient
BLEOMYCIN SULFATE
Application Number
65042
Product Number
2
Dosage Form
-
Strength
EQ 15 UNITS BASE/VIAL
Approval Date
2001-10-17
Regulatory Status
RX
Drug Name
BUPIVACAINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
0.25%
Approval Date
2021-02-11
Active Ingredient
BUPIVACAINE HYDROCHLORIDE
Application Number
205141
Product Number
1
Dosage Form
-
Strength
0.25%
Approval Date
2021-02-11
Regulatory Status
RX
Drug Name
BUPIVACAINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
0.5%
Approval Date
2021-02-11
Active Ingredient
BUPIVACAINE HYDROCHLORIDE
Application Number
205141
Product Number
2
Dosage Form
-
Strength
0.5%
Approval Date
2021-02-11
Regulatory Status
RX
Drug Name
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
Product Number
1
Dosage Form
-
Strength
0.25%
Approval Date
2021-02-11
Active Ingredient
BUPIVACAINE HYDROCHLORIDE
Application Number
204842
Product Number
1
Dosage Form
-
Strength
0.25%
Approval Date
2021-02-11
Regulatory Status
RX
Drug Name
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
Product Number
2
Dosage Form
-
Strength
0.5%
Approval Date
2021-02-11
Active Ingredient
BUPIVACAINE HYDROCHLORIDE
Application Number
204842
Product Number
2
Dosage Form
-
Strength
0.5%
Approval Date
2021-02-11
Regulatory Status
RX
Drug Name
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
Product Number
3
Dosage Form
-
Strength
0.75%
Approval Date
2021-02-11
Active Ingredient
BUPIVACAINE HYDROCHLORIDE
Application Number
204842
Product Number
3
Dosage Form
-
Strength
0.75%
Approval Date
2021-02-11
Regulatory Status
RX
Drug Name
BUPRENORPHINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 0.3MG BASE/ML
Approval Date
2005-03-02
Active Ingredient
BUPRENORPHINE HYDROCHLORIDE
Application Number
76931
Product Number
1
Dosage Form
-
Strength
EQ 0.3MG BASE/ML
Approval Date
2005-03-02
Regulatory Status
RX
Drug Name
BUPRENORPHINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2009-10-08
Active Ingredient
BUPRENORPHINE HYDROCHLORIDE
Application Number
78633
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2009-10-08
Regulatory Status
RX
Drug Name
BUPRENORPHINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 8MG BASE
Approval Date
2009-10-08
Active Ingredient
BUPRENORPHINE HYDROCHLORIDE
Application Number
78633
Product Number
2
Dosage Form
-
Strength
EQ 8MG BASE
Approval Date
2009-10-08
Regulatory Status
RX
Drug Name
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE;EQ 0.5MG BASE
Approval Date
2014-06-27
Active Ingredient
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Application Number
203326
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE;EQ 0.5MG BASE
Approval Date
2014-06-27
Regulatory Status
RX
Drug Name
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 8MG BASE;EQ 2MG BASE
Approval Date
2014-06-27
Active Ingredient
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Application Number
203326
Product Number
2
Dosage Form
-
Strength
EQ 8MG BASE;EQ 2MG BASE
Approval Date
2014-06-27
Regulatory Status
RX
Drug Name
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
Product Number
1
Dosage Form
-
Strength
325MG;50MG;40MG;30MG
Approval Date
2022-01-26
Active Ingredient
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
Application Number
215138
Product Number
1
Dosage Form
-
Strength
325MG;50MG;40MG;30MG
Approval Date
2022-01-26
Regulatory Status
RX
Drug Name
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
Product Number
2
Dosage Form
-
Strength
300MG;50MG;40MG;30MG
Approval Date
2022-01-26
Active Ingredient
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
Application Number
215138
Product Number
2
Dosage Form
-
Strength
300MG;50MG;40MG;30MG
Approval Date
2022-01-26
Regulatory Status
RX
Drug Name
BUTORPHANOL TARTRATE
Product Number
1
Dosage Form
-
Strength
2MG/ML
Approval Date
1998-08-12
Active Ingredient
BUTORPHANOL TARTRATE
Application Number
75046
Product Number
1
Dosage Form
-
Strength
2MG/ML
Approval Date
1998-08-12
Regulatory Status
RX
Drug Name
BUTORPHANOL TARTRATE
Product Number
1
Dosage Form
-
Strength
1MG/SPRAY
Approval Date
2002-03-12
Active Ingredient
BUTORPHANOL TARTRATE
Application Number
75824
Product Number
1
Dosage Form
-
Strength
1MG/SPRAY
Approval Date
2002-03-12
Regulatory Status
RX
Drug Name
BUTORPHANOL TARTRATE
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2009-05-01
Active Ingredient
BUTORPHANOL TARTRATE
Application Number
78400
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2009-05-01
Regulatory Status
RX
Drug Name
BUTORPHANOL TARTRATE
Product Number
2
Dosage Form
-
Strength
2MG/ML
Approval Date
2009-05-01
Active Ingredient
BUTORPHANOL TARTRATE
Application Number
78400
Product Number
2
Dosage Form
-
Strength
2MG/ML
Approval Date
2009-05-01
Regulatory Status
RX
Drug Name
BUTORPHANOL TARTRATE PRESERVATIVE FREE
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
1998-08-12
Active Ingredient
BUTORPHANOL TARTRATE
Application Number
75045
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
1998-08-12
Regulatory Status
RX
Drug Name
BUTORPHANOL TARTRATE PRESERVATIVE FREE
Product Number
2
Dosage Form
-
Strength
2MG/ML
Approval Date
1998-08-12
Active Ingredient
BUTORPHANOL TARTRATE
Application Number
75045
Product Number
2
Dosage Form
-
Strength
2MG/ML
Approval Date
1998-08-12
Regulatory Status
RX
Drug Name
CAFCIT
Product Number
1
Dosage Form
-
Strength
EQ 30MG BASE/3ML (EQ 10MG BASE/ML)
Approval Date
1999-09-21
Active Ingredient
CAFFEINE CITRATE
Application Number
20793
Product Number
1
Dosage Form
-
Strength
EQ 30MG BASE/3ML (EQ 10MG BASE/ML)
Approval Date
1999-09-21
Regulatory Status
RX
Drug Name
CALCITRIOL
Product Number
1
Dosage Form
-
Strength
1MCG/ML
Approval Date
2003-07-18
Active Ingredient
CALCITRIOL
Application Number
76242
Product Number
1
Dosage Form
-
Strength
1MCG/ML
Approval Date
2003-07-18
Regulatory Status
RX
Drug Name
CALCITRIOL
Product Number
1
Dosage Form
-
Strength
0.25MCG
Approval Date
2006-03-27
Active Ingredient
CALCITRIOL
Application Number
76917
Product Number
1
Dosage Form
-
Strength
0.25MCG
Approval Date
2006-03-27
Regulatory Status
RX
Drug Name
CALCIUM ACETATE
Product Number
1
Dosage Form
-
Strength
667MG
Approval Date
2008-02-26
Active Ingredient
CALCIUM ACETATE
Application Number
77728
Product Number
1
Dosage Form
-
Strength
667MG
Approval Date
2008-02-26
Regulatory Status
RX
Drug Name
CAPTOPRIL
Product Number
1
Dosage Form
-
Strength
12.5MG
Approval Date
1996-02-13
Active Ingredient
CAPTOPRIL
Application Number
74505
Product Number
1
Dosage Form
-
Strength
12.5MG
Approval Date
1996-02-13
Regulatory Status
RX
Drug Name
CAPTOPRIL
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
1996-02-13
Active Ingredient
CAPTOPRIL
Application Number
74505
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
1996-02-13
Regulatory Status
RX
Drug Name
CAPTOPRIL
Product Number
3
Dosage Form
-
Strength
50MG
Approval Date
1996-02-13
Active Ingredient
CAPTOPRIL
Application Number
74505
Product Number
3
Dosage Form
-
Strength
50MG
Approval Date
1996-02-13
Regulatory Status
RX
Drug Name
CAPTOPRIL
Product Number
4
Dosage Form
-
Strength
100MG
Approval Date
1996-02-13
Active Ingredient
CAPTOPRIL
Application Number
74505
Product Number
4
Dosage Form
-
Strength
100MG
Approval Date
1996-02-13
Regulatory Status
RX
Drug Name
CARBOPLATIN
Product Number
1
Dosage Form
-
Strength
50MG/5ML (10MG/ML)
Approval Date
2004-10-15
Active Ingredient
CARBOPLATIN
Application Number
77244
Product Number
1
Dosage Form
-
Strength
50MG/5ML (10MG/ML)
Approval Date
2004-10-15
Regulatory Status
RX
Drug Name
CARBOPLATIN
Product Number
2
Dosage Form
-
Strength
150MG/15ML (10MG/ML)
Approval Date
2004-10-15
Active Ingredient
CARBOPLATIN
Application Number
77244
Product Number
2
Dosage Form
-
Strength
150MG/15ML (10MG/ML)
Approval Date
2004-10-15
Regulatory Status
RX
Drug Name
CARBOPLATIN
Product Number
3
Dosage Form
-
Strength
450MG/45ML (10MG/ML)
Approval Date
2004-10-15
Active Ingredient
CARBOPLATIN
Application Number
77244
Product Number
3
Dosage Form
-
Strength
450MG/45ML (10MG/ML)
Approval Date
2004-10-15
Regulatory Status
RX
Drug Name
CARBOPLATIN
Product Number
4
Dosage Form
-
Strength
600MG/60ML (10MG/ML)
Approval Date
2006-01-20
Active Ingredient
CARBOPLATIN
Application Number
77244
Product Number
4
Dosage Form
-
Strength
600MG/60ML (10MG/ML)
Approval Date
2006-01-20
Regulatory Status
RX
Drug Name
CEFAZOLIN SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2001-09-18
Active Ingredient
CEFAZOLIN SODIUM
Application Number
65047
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2001-09-18
Regulatory Status
RX
Drug Name
CEFAZOLIN SODIUM
Product Number
2
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
2001-09-18
Active Ingredient
CEFAZOLIN SODIUM
Application Number
65047
Product Number
2
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
2001-09-18
Regulatory Status
RX
Drug Name
CEFAZOLIN SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 10GM BASE/VIAL
Approval Date
2004-10-18
Active Ingredient
CEFAZOLIN SODIUM
Application Number
65143
Product Number
1
Dosage Form
-
Strength
EQ 10GM BASE/VIAL
Approval Date
2004-10-18
Regulatory Status
RX
Drug Name
CEFAZOLIN SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 2GM BASE/VIAL
Approval Date
2022-10-07
Active Ingredient
CEFAZOLIN SODIUM
Application Number
216109
Product Number
1
Dosage Form
-
Strength
EQ 2GM BASE/VIAL
Approval Date
2022-10-07
Regulatory Status
RX
Drug Name
CEFAZOLIN SODIUM
Product Number
2
Dosage Form
-
Strength
EQ 3GM BASE/VIAL
Approval Date
2022-10-07
Active Ingredient
CEFAZOLIN SODIUM
Application Number
216109
Product Number
2
Dosage Form
-
Strength
EQ 3GM BASE/VIAL
Approval Date
2022-10-07
Regulatory Status
RX
Drug Name
CEFEPIME HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
2024-05-22
Active Ingredient
CEFEPIME HYDROCHLORIDE
Application Number
214402
Product Number
1
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
2024-05-22
Regulatory Status
RX
Drug Name
CEFEPIME HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 2GM BASE/VIAL
Approval Date
2024-05-22
Active Ingredient
CEFEPIME HYDROCHLORIDE
Application Number
214402
Product Number
2
Dosage Form
-
Strength
EQ 2GM BASE/VIAL
Approval Date
2024-05-22
Regulatory Status
RX
Drug Name
CEFOXITIN
Product Number
1
Dosage Form
-
Strength
EQ 10GM BASE/VIAL
Approval Date
2000-09-11
Active Ingredient
CEFOXITIN SODIUM
Application Number
65050
Product Number
1
Dosage Form
-
Strength
EQ 10GM BASE/VIAL
Approval Date
2000-09-11
Regulatory Status
RX
Drug Name
CEFOXITIN
Product Number
1
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
2000-09-11
Active Ingredient
CEFOXITIN SODIUM
Application Number
65051
Product Number
1
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
2000-09-11
Regulatory Status
RX
Drug Name
CEFOXITIN
Product Number
2
Dosage Form
-
Strength
EQ 2GM BASE/VIAL
Approval Date
2000-09-11
Active Ingredient
CEFOXITIN SODIUM
Application Number
65051
Product Number
2
Dosage Form
-
Strength
EQ 2GM BASE/VIAL
Approval Date
2000-09-11
Regulatory Status
RX
Drug Name
CEFOXITIN
Product Number
1
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
2010-03-12
Active Ingredient
CEFOXITIN SODIUM
Application Number
65238
Product Number
1
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
2010-03-12
Regulatory Status
RX
Drug Name
CEFOXITIN
Product Number
2
Dosage Form
-
Strength
EQ 2GM BASE/VIAL
Approval Date
2010-03-12
Active Ingredient
CEFOXITIN SODIUM
Application Number
65238
Product Number
2
Dosage Form
-
Strength
EQ 2GM BASE/VIAL
Approval Date
2010-03-12
Regulatory Status
RX
Drug Name
CEFOXITIN
Product Number
1
Dosage Form
-
Strength
EQ 10GM BASE/VIAL
Approval Date
2010-03-02
Active Ingredient
CEFOXITIN SODIUM
Application Number
65239
Product Number
1
Dosage Form
-
Strength
EQ 10GM BASE/VIAL
Approval Date
2010-03-02
Regulatory Status
RX
Drug Name
CEFTRIAXONE
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE/VIAL
Approval Date
2008-01-10
Active Ingredient
CEFTRIAXONE SODIUM
Application Number
65342
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE/VIAL
Approval Date
2008-01-10
Regulatory Status
RX
Drug Name
CEFTRIAXONE
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2008-01-10
Active Ingredient
CEFTRIAXONE SODIUM
Application Number
65342
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2008-01-10
Regulatory Status
RX
Drug Name
CEFTRIAXONE
Product Number
3
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
2008-01-10
Active Ingredient
CEFTRIAXONE SODIUM
Application Number
65342
Product Number
3
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
2008-01-10
Regulatory Status
RX
Drug Name
CEFTRIAXONE
Product Number
4
Dosage Form
-
Strength
EQ 2GM BASE/VIAL
Approval Date
2008-01-10
Active Ingredient
CEFTRIAXONE SODIUM
Application Number
65342
Product Number
4
Dosage Form
-
Strength
EQ 2GM BASE/VIAL
Approval Date
2008-01-10
Regulatory Status
RX
Drug Name
CEFTRIAXONE SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 10GM BASE/VIAL
Approval Date
2017-10-04
Active Ingredient
CEFTRIAXONE SODIUM
Application Number
90701
Product Number
1
Dosage Form
-
Strength
EQ 10GM BASE/VIAL
Approval Date
2017-10-04
Regulatory Status
RX
Drug Name
CEFUROXIME SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 750MG BASE/VIAL
Approval Date
2004-01-09
Active Ingredient
CEFUROXIME SODIUM
Application Number
65048
Product Number
1
Dosage Form
-
Strength
EQ 750MG BASE/VIAL
Approval Date
2004-01-09
Regulatory Status
RX
Drug Name
CEFUROXIME SODIUM
Product Number
2
Dosage Form
-
Strength
EQ 1.5GM BASE/VIAL
Approval Date
2004-01-09
Active Ingredient
CEFUROXIME SODIUM
Application Number
65048
Product Number
2
Dosage Form
-
Strength
EQ 1.5GM BASE/VIAL
Approval Date
2004-01-09
Regulatory Status
RX
Drug Name
CERUBIDINE
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE/VIAL
Approval Date
1995-02-03
Active Ingredient
DAUNORUBICIN HYDROCHLORIDE
Application Number
64103
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE/VIAL
Approval Date
1995-02-03
Regulatory Status
RX
Drug Name
CEVIMELINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
2013-07-08
Active Ingredient
CEVIMELINE HYDROCHLORIDE
Application Number
91591
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
2013-07-08
Regulatory Status
RX
Drug Name
CHLOROPROCAINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
2%
Approval Date
1998-09-09
Active Ingredient
CHLOROPROCAINE HYDROCHLORIDE
Application Number
40273
Product Number
1
Dosage Form
-
Strength
2%
Approval Date
1998-09-09
Regulatory Status
RX
Drug Name
CHLOROPROCAINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
3%
Approval Date
1998-09-09
Active Ingredient
CHLOROPROCAINE HYDROCHLORIDE
Application Number
40273
Product Number
2
Dosage Form
-
Strength
3%
Approval Date
1998-09-09
Regulatory Status
RX
Drug Name
CHLORPROMAZINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
25MG/ML
Approval Date
1982-01-01
Active Ingredient
CHLORPROMAZINE HYDROCHLORIDE
Application Number
83329
Product Number
1
Dosage Form
-
Strength
25MG/ML
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
CIPROFLOXACIN
Product Number
1
Dosage Form
-
Strength
200MG/20ML (10MG/ML)
Approval Date
2009-12-22
Active Ingredient
CIPROFLOXACIN
Application Number
76717
Product Number
1
Dosage Form
-
Strength
200MG/20ML (10MG/ML)
Approval Date
2009-12-22
Regulatory Status
RX
Drug Name
CIPROFLOXACIN
Product Number
2
Dosage Form
-
Strength
400MG/40ML (10MG/ML)
Approval Date
2009-12-22
Active Ingredient
CIPROFLOXACIN
Application Number
76717
Product Number
2
Dosage Form
-
Strength
400MG/40ML (10MG/ML)
Approval Date
2009-12-22
Regulatory Status
RX
Drug Name
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Product Number
1
Dosage Form
-
Strength
400MG/200ML
Approval Date
2009-11-18
Active Ingredient
CIPROFLOXACIN
Application Number
78431
Product Number
1
Dosage Form
-
Strength
400MG/200ML
Approval Date
2009-11-18
Regulatory Status
RX
Drug Name
CISATRACURIUM BESYLATE
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE/ML
Approval Date
2022-06-28
Active Ingredient
CISATRACURIUM BESYLATE
Application Number
203078
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE/ML
Approval Date
2022-06-28
Regulatory Status
RX
Drug Name
CISATRACURIUM BESYLATE
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE/ML
Approval Date
2023-12-18
Active Ingredient
CISATRACURIUM BESYLATE
Application Number
203078
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE/ML
Approval Date
2023-12-18
Regulatory Status
RX
Drug Name
CISATRACURIUM BESYLATE
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE/ML
Approval Date
2023-04-19
Active Ingredient
CISATRACURIUM BESYLATE
Application Number
203079
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE/ML
Approval Date
2023-04-19
Regulatory Status
RX
Drug Name
CISPLATIN
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2000-11-07
Active Ingredient
CISPLATIN
Application Number
75036
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2000-11-07
Regulatory Status
RX
Drug Name
CITALOPRAM HYDROBROMIDE
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/5ML
Approval Date
2004-12-13
Active Ingredient
CITALOPRAM HYDROBROMIDE
Application Number
77043
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/5ML
Approval Date
2004-12-13
Regulatory Status
RX
Drug Name
CLADRIBINE
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2000-02-28
Active Ingredient
CLADRIBINE
Application Number
75405
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2000-02-28
Regulatory Status
RX
Drug Name
CLINDAMYCIN PHOSPHATE
Product Number
1
Dosage Form
-
Strength
EQ 150MG BASE/ML
Approval Date
1988-04-25
Active Ingredient
CLINDAMYCIN PHOSPHATE
Application Number
62889
Product Number
1
Dosage Form
-
Strength
EQ 150MG BASE/ML
Approval Date
1988-04-25
Regulatory Status
RX
Drug Name
CLINDAMYCIN PHOSPHATE
Product Number
1
Dosage Form
-
Strength
EQ 150MG BASE/ML
Approval Date
2004-09-24
Active Ingredient
CLINDAMYCIN PHOSPHATE
Application Number
65206
Product Number
1
Dosage Form
-
Strength
EQ 150MG BASE/ML
Approval Date
2004-09-24
Regulatory Status
RX
Drug Name
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%
Product Number
1
Dosage Form
-
Strength
EQ 6MG BASE/ML
Approval Date
2023-04-05
Active Ingredient
CLINDAMYCIN PHOSPHATE
Application Number
214401
Product Number
1
Dosage Form
-
Strength
EQ 6MG BASE/ML
Approval Date
2023-04-05
Regulatory Status
RX
Drug Name
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%
Product Number
2
Dosage Form
-
Strength
EQ 12MG BASE/ML
Approval Date
2023-04-05
Active Ingredient
CLINDAMYCIN PHOSPHATE
Application Number
214401
Product Number
2
Dosage Form
-
Strength
EQ 12MG BASE/ML
Approval Date
2023-04-05
Regulatory Status
RX
Drug Name
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%
Product Number
3
Dosage Form
-
Strength
EQ 18MG BASE/ML
Approval Date
2023-04-05
Active Ingredient
CLINDAMYCIN PHOSPHATE
Application Number
214401
Product Number
3
Dosage Form
-
Strength
EQ 18MG BASE/ML
Approval Date
2023-04-05
Regulatory Status
RX
Drug Name
CLONIDINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
1MG/10ML (0.1MG/ML)
Approval Date
2011-01-26
Active Ingredient
CLONIDINE HYDROCHLORIDE
Application Number
200300
Product Number
1
Dosage Form
-
Strength
1MG/10ML (0.1MG/ML)
Approval Date
2011-01-26
Regulatory Status
RX
Drug Name
CLONIDINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
5MG/10ML (0.5MG/ML)
Approval Date
2011-01-26
Active Ingredient
CLONIDINE HYDROCHLORIDE
Application Number
200300
Product Number
2
Dosage Form
-
Strength
5MG/10ML (0.5MG/ML)
Approval Date
2011-01-26
Regulatory Status
RX
Drug Name
CLOTRIMAZOLE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2004-07-29
Active Ingredient
CLOTRIMAZOLE
Application Number
76387
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2004-07-29
Regulatory Status
RX
Drug Name
CODEINE SULFATE
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
2009-07-16
Active Ingredient
CODEINE SULFATE
Application Number
22402
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
2009-07-16
Regulatory Status
RX
Drug Name
CODEINE SULFATE
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
2009-07-16
Active Ingredient
CODEINE SULFATE
Application Number
22402
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
2009-07-16
Regulatory Status
RX
Drug Name
CODEINE SULFATE
Product Number
3
Dosage Form
-
Strength
60MG
Approval Date
2009-07-16
Active Ingredient
CODEINE SULFATE
Application Number
22402
Product Number
3
Dosage Form
-
Strength
60MG
Approval Date
2009-07-16
Regulatory Status
RX
Drug Name
COMBOGESIC IV
Product Number
1
Dosage Form
-
Strength
1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML)
Approval Date
2023-10-17
Active Ingredient
ACETAMINOPHEN; IBUPROFEN SODIUM
Application Number
215320
Product Number
1
Dosage Form
-
Strength
1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML)
Approval Date
2023-10-17
Regulatory Status
RX
Drug Name
CYCLOPHOSPHAMIDE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2013-09-16
Active Ingredient
CYCLOPHOSPHAMIDE
Application Number
203856
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2013-09-16
Regulatory Status
RX
Drug Name
CYCLOPHOSPHAMIDE
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2013-09-16
Active Ingredient
CYCLOPHOSPHAMIDE
Application Number
203856
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2013-09-16
Regulatory Status
RX
Drug Name
CYCLOPHOSPHAMIDE
Product Number
1
Dosage Form
-
Strength
500MG/VIAL
Approval Date
2023-12-18
Active Ingredient
CYCLOPHOSPHAMIDE
Application Number
216958
Product Number
1
Dosage Form
-
Strength
500MG/VIAL
Approval Date
2023-12-18
Regulatory Status
RX
Drug Name
CYCLOPHOSPHAMIDE
Product Number
2
Dosage Form
-
Strength
1GM/VIAL
Approval Date
2023-12-18
Active Ingredient
CYCLOPHOSPHAMIDE
Application Number
216958
Product Number
2
Dosage Form
-
Strength
1GM/VIAL
Approval Date
2023-12-18
Regulatory Status
RX
Drug Name
CYCLOPHOSPHAMIDE
Product Number
3
Dosage Form
-
Strength
2GM/VIAL
Approval Date
2023-12-18
Active Ingredient
CYCLOPHOSPHAMIDE
Application Number
216958
Product Number
3
Dosage Form
-
Strength
2GM/VIAL
Approval Date
2023-12-18
Regulatory Status
RX
Drug Name
CYCLOSPORINE
Product Number
1
Dosage Form
-
Strength
50MG/ML
Approval Date
1999-10-29
Active Ingredient
CYCLOSPORINE
Application Number
65004
Product Number
1
Dosage Form
-
Strength
50MG/ML
Approval Date
1999-10-29
Regulatory Status
RX
Drug Name
CYTARABINE
Product Number
1
Dosage Form
-
Strength
100MG/VIAL
Approval Date
1989-08-02
Active Ingredient
CYTARABINE
Application Number
71471
Product Number
1
Dosage Form
-
Strength
100MG/VIAL
Approval Date
1989-08-02
Regulatory Status
RX
Drug Name
CYTARABINE
Product Number
1
Dosage Form
-
Strength
500MG/VIAL
Approval Date
1989-08-02
Active Ingredient
CYTARABINE
Application Number
71472
Product Number
1
Dosage Form
-
Strength
500MG/VIAL
Approval Date
1989-08-02
Regulatory Status
RX
Drug Name
DACARBAZINE
Product Number
1
Dosage Form
-
Strength
200MG/VIAL
Approval Date
2001-06-15
Active Ingredient
DACARBAZINE
Application Number
75812
Product Number
1
Dosage Form
-
Strength
200MG/VIAL
Approval Date
2001-06-15
Regulatory Status
RX
Drug Name
DACARBAZINE
Product Number
2
Dosage Form
-
Strength
500MG/VIAL
Approval Date
2002-10-31
Active Ingredient
DACARBAZINE
Application Number
75812
Product Number
2
Dosage Form
-
Strength
500MG/VIAL
Approval Date
2002-10-31
Regulatory Status
RX
Drug Name
DANTROLENE SODIUM
Product Number
1
Dosage Form
-
Strength
20MG/VIAL
Approval Date
2017-06-19
Active Ingredient
DANTROLENE SODIUM
Application Number
204762
Product Number
1
Dosage Form
-
Strength
20MG/VIAL
Approval Date
2017-06-19
Regulatory Status
RX
Drug Name
DAPTOMYCIN
Product Number
1
Dosage Form
-
Strength
350MG/VIAL
Approval Date
2017-10-20
Active Ingredient
DAPTOMYCIN
Application Number
209949
Product Number
1
Dosage Form
-
Strength
350MG/VIAL
Approval Date
2017-10-20
Regulatory Status
RX
Drug Name
DAPTOMYCIN
Product Number
1
Dosage Form
-
Strength
350MG/VIAL
Approval Date
2023-01-30
Active Ingredient
DAPTOMYCIN
Application Number
217415
Product Number
1
Dosage Form
-
Strength
350MG/VIAL
Approval Date
2023-01-30
Regulatory Status
RX
Drug Name
DAPTOMYCIN
Product Number
2
Dosage Form
-
Strength
500MG/VIAL
Approval Date
2023-01-30
Active Ingredient
DAPTOMYCIN
Application Number
217415
Product Number
2
Dosage Form
-
Strength
500MG/VIAL
Approval Date
2023-01-30
Regulatory Status
RX
Drug Name
DAUNORUBICIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/ML
Approval Date
1998-01-30
Active Ingredient
DAUNORUBICIN HYDROCHLORIDE
Application Number
50731
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/ML
Approval Date
1998-01-30
Regulatory Status
RX
Drug Name
DEFERIPRONE
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2021-03-29
Active Ingredient
DEFERIPRONE
Application Number
213239
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2021-03-29
Regulatory Status
RX
Drug Name
DEFERIPRONE
Product Number
2
Dosage Form
-
Strength
1GM
Approval Date
2022-02-08
Active Ingredient
DEFERIPRONE
Application Number
213239
Product Number
2
Dosage Form
-
Strength
1GM
Approval Date
2022-02-08
Regulatory Status
RX
Drug Name
DESVENLAFAXINE SUCCINATE
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2016-02-16
Active Ingredient
DESVENLAFAXINE SUCCINATE
Application Number
204083
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2016-02-16
Regulatory Status
RX
Drug Name
DESVENLAFAXINE SUCCINATE
Product Number
2
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2016-02-16
Active Ingredient
DESVENLAFAXINE SUCCINATE
Application Number
204083
Product Number
2
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2016-02-16
Regulatory Status
RX
Drug Name
DESVENLAFAXINE SUCCINATE
Product Number
3
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2016-02-16
Active Ingredient
DESVENLAFAXINE SUCCINATE
Application Number
204083
Product Number
3
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2016-02-16
Regulatory Status
RX
Drug Name
DEXAMETHASONE
Product Number
1
Dosage Form
-
Strength
4MG
Approval Date
1982-01-01
Active Ingredient
DEXAMETHASONE
Application Number
84612
Product Number
1
Dosage Form
-
Strength
4MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
DEXAMETHASONE
Product Number
2
Dosage Form
-
Strength
0.5MG
Approval Date
1982-01-01
Active Ingredient
DEXAMETHASONE
Application Number
84612
Product Number
2
Dosage Form
-
Strength
0.5MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
DEXAMETHASONE
Product Number
3
Dosage Form
-
Strength
0.75MG
Approval Date
1982-01-01
Active Ingredient
DEXAMETHASONE
Application Number
84612
Product Number
3
Dosage Form
-
Strength
0.75MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
DEXAMETHASONE
Product Number
4
Dosage Form
-
Strength
1MG
Approval Date
1983-09-15
Active Ingredient
DEXAMETHASONE
Application Number
84612
Product Number
4
Dosage Form
-
Strength
1MG
Approval Date
1983-09-15
Regulatory Status
RX
Drug Name
DEXAMETHASONE
Product Number
5
Dosage Form
-
Strength
1.5MG
Approval Date
1982-01-01
Active Ingredient
DEXAMETHASONE
Application Number
84612
Product Number
5
Dosage Form
-
Strength
1.5MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
DEXAMETHASONE
Product Number
6
Dosage Form
-
Strength
2MG
Approval Date
1982-01-01
Active Ingredient
DEXAMETHASONE
Application Number
84612
Product Number
6
Dosage Form
-
Strength
2MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
DEXAMETHASONE
Product Number
7
Dosage Form
-
Strength
6MG
Approval Date
1983-09-15
Active Ingredient
DEXAMETHASONE
Application Number
84612
Product Number
7
Dosage Form
-
Strength
6MG
Approval Date
1983-09-15
Regulatory Status
RX
Drug Name
DEXAMETHASONE
Product Number
1
Dosage Form
-
Strength
0.5MG/5ML
Approval Date
1983-09-01
Active Ingredient
DEXAMETHASONE
Application Number
88248
Product Number
1
Dosage Form
-
Strength
0.5MG/5ML
Approval Date
1983-09-01
Regulatory Status
RX
Drug Name
DEXAMETHASONE INTENSOL
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
1983-09-01
Active Ingredient
DEXAMETHASONE
Application Number
88252
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
1983-09-01
Regulatory Status
RX
Drug Name
DEXAMETHASONE SODIUM PHOSPHATE
Product Number
1
Dosage Form
-
Strength
EQ 4MG PHOSPHATE/ML
Approval Date
1982-01-01
Active Ingredient
DEXAMETHASONE SODIUM PHOSPHATE
Application Number
84282
Product Number
1
Dosage Form
-
Strength
EQ 4MG PHOSPHATE/ML
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
DEXAMETHASONE SODIUM PHOSPHATE
Product Number
1
Dosage Form
-
Strength
EQ 10MG PHOSPHATE/ML
Approval Date
1982-09-07
Active Ingredient
DEXAMETHASONE SODIUM PHOSPHATE
Application Number
87702
Product Number
1
Dosage Form
-
Strength
EQ 10MG PHOSPHATE/ML
Approval Date
1982-09-07
Regulatory Status
RX
Drug Name
DEXMEDETOMIDINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)
Approval Date
2017-04-26
Active Ingredient
DEXMEDETOMIDINE HYDROCHLORIDE
Application Number
205046
Product Number
1
Dosage Form
-
Strength
EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)
Approval Date
2017-04-26
Regulatory Status
RX
Drug Name
DEXMEDETOMIDINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)
Approval Date
2020-01-30
Active Ingredient
DEXMEDETOMIDINE HYDROCHLORIDE
Application Number
206407
Product Number
1
Dosage Form
-
Strength
EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)
Approval Date
2020-01-30
Regulatory Status
RX
Drug Name
DEXMEDETOMIDINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)
Approval Date
2020-01-30
Active Ingredient
DEXMEDETOMIDINE HYDROCHLORIDE
Application Number
206407
Product Number
2
Dosage Form
-
Strength
EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)
Approval Date
2020-01-30
Regulatory Status
RX
Drug Name
DEXMEDETOMIDINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 1MG BASE/250ML (EQ 4MCG BASE/ML)
Approval Date
2025-05-30
Active Ingredient
DEXMEDETOMIDINE HYDROCHLORIDE
Application Number
206407
Product Number
3
Dosage Form
-
Strength
EQ 1MG BASE/250ML (EQ 4MCG BASE/ML)
Approval Date
2025-05-30
Regulatory Status
RX
Drug Name
DEXRAZOXANE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE/VIAL
Approval Date
2004-09-28
Active Ingredient
DEXRAZOXANE HYDROCHLORIDE
Application Number
76068
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE/VIAL
Approval Date
2004-09-28
Regulatory Status
RX
Drug Name
DEXRAZOXANE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2004-09-28
Active Ingredient
DEXRAZOXANE HYDROCHLORIDE
Application Number
76068
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2004-09-28
Regulatory Status
RX
Drug Name
DIAZEPAM
Product Number
1
Dosage Form
-
Strength
50MG/10ML (5MG/ML)
Approval Date
1985-12-16
Active Ingredient
DIAZEPAM
Application Number
70311
Product Number
1
Dosage Form
-
Strength
50MG/10ML (5MG/ML)
Approval Date
1985-12-16
Regulatory Status
RX
Drug Name
DIAZEPAM
Product Number
1
Dosage Form
-
Strength
10MG/2ML (5MG/ML)
Approval Date
1985-12-16
Active Ingredient
DIAZEPAM
Application Number
70313
Product Number
1
Dosage Form
-
Strength
10MG/2ML (5MG/ML)
Approval Date
1985-12-16
Regulatory Status
RX
Drug Name
DIAZEPAM
Product Number
1
Dosage Form
-
Strength
5MG/5ML
Approval Date
1987-04-03
Active Ingredient
DIAZEPAM
Application Number
70928
Product Number
1
Dosage Form
-
Strength
5MG/5ML
Approval Date
1987-04-03
Regulatory Status
RX
Drug Name
DIAZEPAM INTENSOL
Product Number
1
Dosage Form
-
Strength
5MG/ML
Approval Date
1987-04-03
Active Ingredient
DIAZEPAM
Application Number
71415
Product Number
1
Dosage Form
-
Strength
5MG/ML
Approval Date
1987-04-03
Regulatory Status
RX
Drug Name
DICYCLOMINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
1996-10-01
Active Ingredient
DICYCLOMINE HYDROCHLORIDE
Application Number
40161
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
1996-10-01
Regulatory Status
RX
Drug Name
DICYCLOMINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG/5ML
Approval Date
2020-05-22
Active Ingredient
DICYCLOMINE HYDROCHLORIDE
Application Number
212286
Product Number
1
Dosage Form
-
Strength
10MG/5ML
Approval Date
2020-05-22
Regulatory Status
RX
Drug Name
DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE)
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2003-06-30
Active Ingredient
DICYCLOMINE HYDROCHLORIDE
Application Number
40465
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2003-06-30
Regulatory Status
RX
Drug Name
DIGOXIN
Product Number
1
Dosage Form
-
Strength
0.05MG/ML
Approval Date
2004-08-26
Active Ingredient
DIGOXIN
Application Number
21648
Product Number
1
Dosage Form
-
Strength
0.05MG/ML
Approval Date
2004-08-26
Regulatory Status
RX
Drug Name
DIGOXIN
Product Number
1
Dosage Form
-
Strength
0.25MG
Approval Date
2007-10-30
Active Ingredient
DIGOXIN
Application Number
77002
Product Number
1
Dosage Form
-
Strength
0.25MG
Approval Date
2007-10-30
Regulatory Status
RX
Drug Name
DIGOXIN
Product Number
2
Dosage Form
-
Strength
0.125MG
Approval Date
2007-10-30
Active Ingredient
DIGOXIN
Application Number
77002
Product Number
2
Dosage Form
-
Strength
0.125MG
Approval Date
2007-10-30
Regulatory Status
RX
Drug Name
DIGOXIN
Product Number
1
Dosage Form
-
Strength
0.25MG/ML
Approval Date
1982-01-01
Active Ingredient
DIGOXIN
Application Number
83391
Product Number
1
Dosage Form
-
Strength
0.25MG/ML
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
DIHYDROERGOTAMINE MESYLATE
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2003-06-09
Active Ingredient
DIHYDROERGOTAMINE MESYLATE
Application Number
40453
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2003-06-09
Regulatory Status
RX
Drug Name
DIHYDROERGOTAMINE MESYLATE
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2017-09-15
Active Ingredient
DIHYDROERGOTAMINE MESYLATE
Application Number
206621
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2017-09-15
Regulatory Status
RX
Drug Name
DIHYDROERGOTAMINE MESYLATE
Product Number
1
Dosage Form
-
Strength
0.5MG/SPRAY
Approval Date
2020-02-28
Active Ingredient
DIHYDROERGOTAMINE MESYLATE
Application Number
211393
Product Number
1
Dosage Form
-
Strength
0.5MG/SPRAY
Approval Date
2020-02-28
Regulatory Status
RX
Drug Name
DILTIAZEM HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
5MG/ML
Approval Date
2008-12-17
Active Ingredient
DILTIAZEM HYDROCHLORIDE
Application Number
78538
Product Number
1
Dosage Form
-
Strength
5MG/ML
Approval Date
2008-12-17
Regulatory Status
RX
Drug Name
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
Product Number
1
Dosage Form
-
Strength
0.025MG/5ML;2.5MG/5ML
Approval Date
1982-05-03
Active Ingredient
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
Application Number
87708
Product Number
1
Dosage Form
-
Strength
0.025MG/5ML;2.5MG/5ML
Approval Date
1982-05-03
Regulatory Status
RX
Drug Name
DIPYRIDAMOLE
Product Number
1
Dosage Form
-
Strength
5MG/ML
Approval Date
1996-10-18
Active Ingredient
DIPYRIDAMOLE
Application Number
74521
Product Number
1
Dosage Form
-
Strength
5MG/ML
Approval Date
1996-10-18
Regulatory Status
RX
Drug Name
DOBUTAMINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 12.5MG BASE/ML
Approval Date
1994-10-31
Active Ingredient
DOBUTAMINE HYDROCHLORIDE
Application Number
74277
Product Number
1
Dosage Form
-
Strength
EQ 12.5MG BASE/ML
Approval Date
1994-10-31
Regulatory Status
RX
Drug Name
DOCETAXEL
Product Number
1
Dosage Form
-
Strength
20MG/ML (20MG/ML)
Approval Date
2021-01-14
Active Ingredient
DOCETAXEL
Application Number
204490
Product Number
1
Dosage Form
-
Strength
20MG/ML (20MG/ML)
Approval Date
2021-01-14
Regulatory Status
RX
Drug Name
DOCETAXEL
Product Number
2
Dosage Form
-
Strength
80MG/4ML (20MG/ML)
Approval Date
2021-01-14
Active Ingredient
DOCETAXEL
Application Number
204490
Product Number
2
Dosage Form
-
Strength
80MG/4ML (20MG/ML)
Approval Date
2021-01-14
Regulatory Status
RX
Drug Name
DOPAMINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
40MG/ML
Approval Date
2018-04-11
Active Ingredient
DOPAMINE HYDROCHLORIDE
Application Number
207707
Product Number
1
Dosage Form
-
Strength
40MG/ML
Approval Date
2018-04-11
Regulatory Status
RX
Drug Name
DOPAMINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
80MG/ML
Approval Date
2018-04-11
Active Ingredient
DOPAMINE HYDROCHLORIDE
Application Number
207707
Product Number
2
Dosage Form
-
Strength
80MG/ML
Approval Date
2018-04-11
Regulatory Status
RX
Drug Name
DOPRAM
Product Number
1
Dosage Form
-
Strength
20MG/ML
Approval Date
1982-01-01
Active Ingredient
DOXAPRAM HYDROCHLORIDE
Application Number
14879
Product Number
1
Dosage Form
-
Strength
20MG/ML
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
DOXORUBICIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG/VIAL
Approval Date
1989-03-17
Active Ingredient
DOXORUBICIN HYDROCHLORIDE
Application Number
62921
Product Number
1
Dosage Form
-
Strength
10MG/VIAL
Approval Date
1989-03-17
Regulatory Status
RX
Drug Name
DOXORUBICIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
20MG/VIAL
Approval Date
1989-03-17
Active Ingredient
DOXORUBICIN HYDROCHLORIDE
Application Number
62921
Product Number
2
Dosage Form
-
Strength
20MG/VIAL
Approval Date
1989-03-17
Regulatory Status
RX
Drug Name
DOXORUBICIN HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
50MG/VIAL
Approval Date
1989-03-17
Active Ingredient
DOXORUBICIN HYDROCHLORIDE
Application Number
62921
Product Number
3
Dosage Form
-
Strength
50MG/VIAL
Approval Date
1989-03-17
Regulatory Status
RX
Drug Name
DOXORUBICIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
2MG/ML
Approval Date
1989-03-17
Active Ingredient
DOXORUBICIN HYDROCHLORIDE
Application Number
62975
Product Number
1
Dosage Form
-
Strength
2MG/ML
Approval Date
1989-03-17
Regulatory Status
RX
Drug Name
DOXORUBICIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
200MG/100ML
Approval Date
1994-09-13
Active Ingredient
DOXORUBICIN HYDROCHLORIDE
Application Number
64097
Product Number
1
Dosage Form
-
Strength
200MG/100ML
Approval Date
1994-09-13
Regulatory Status
RX
Drug Name
DOXYCYCLINE HYCLATE
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
1984-05-07
Active Ingredient
DOXYCYCLINE HYCLATE
Application Number
62396
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
1984-05-07
Regulatory Status
RX
Drug Name
DOXYCYCLINE HYCLATE
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
1984-11-07
Active Ingredient
DOXYCYCLINE HYCLATE
Application Number
62396
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
1984-11-07
Regulatory Status
RX
Drug Name
DOXYCYCLINE HYCLATE
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2003-07-02
Active Ingredient
DOXYCYCLINE HYCLATE
Application Number
65095
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2003-07-02
Regulatory Status
RX
Drug Name
DROPERIDOL
Product Number
1
Dosage Form
-
Strength
2.5MG/ML
Approval Date
2017-12-14
Active Ingredient
DROPERIDOL
Application Number
208197
Product Number
1
Dosage Form
-
Strength
2.5MG/ML
Approval Date
2017-12-14
Regulatory Status
RX
Drug Name
DURAMORPH PF
Product Number
1
Dosage Form
-
Strength
0.5MG/ML
Approval Date
1984-09-18
Active Ingredient
MORPHINE SULFATE
Application Number
18565
Product Number
1
Dosage Form
-
Strength
0.5MG/ML
Approval Date
1984-09-18
Regulatory Status
RX
Drug Name
DURAMORPH PF
Product Number
2
Dosage Form
-
Strength
1MG/ML
Approval Date
1984-09-18
Active Ingredient
MORPHINE SULFATE
Application Number
18565
Product Number
2
Dosage Form
-
Strength
1MG/ML
Approval Date
1984-09-18
Regulatory Status
RX
Drug Name
EDARAVONE
Product Number
1
Dosage Form
-
Strength
30MG/100ML (0.3MG/ML)
Approval Date
2024-05-06
Active Ingredient
EDARAVONE
Application Number
215508
Product Number
1
Dosage Form
-
Strength
30MG/100ML (0.3MG/ML)
Approval Date
2024-05-06
Regulatory Status
RX
Drug Name
ELTROMBOPAG OLAMINE
Product Number
1
Dosage Form
-
Strength
EQ 12.5MG ACID
Approval Date
2026-04-08
Active Ingredient
ELTROMBOPAG OLAMINE
Application Number
220033
Product Number
1
Dosage Form
-
Strength
EQ 12.5MG ACID
Approval Date
2026-04-08
Regulatory Status
RX
Drug Name
ELTROMBOPAG OLAMINE
Product Number
2
Dosage Form
-
Strength
EQ 25MG ACID
Approval Date
2026-04-08
Active Ingredient
ELTROMBOPAG OLAMINE
Application Number
220033
Product Number
2
Dosage Form
-
Strength
EQ 25MG ACID
Approval Date
2026-04-08
Regulatory Status
RX
Drug Name
ELTROMBOPAG OLAMINE
Product Number
3
Dosage Form
-
Strength
EQ 50MG ACID
Approval Date
2026-04-08
Active Ingredient
ELTROMBOPAG OLAMINE
Application Number
220033
Product Number
3
Dosage Form
-
Strength
EQ 50MG ACID
Approval Date
2026-04-08
Regulatory Status
RX
Drug Name
ELTROMBOPAG OLAMINE
Product Number
4
Dosage Form
-
Strength
EQ 75MG ACID
Approval Date
2026-04-08
Active Ingredient
ELTROMBOPAG OLAMINE
Application Number
220033
Product Number
4
Dosage Form
-
Strength
EQ 75MG ACID
Approval Date
2026-04-08
Regulatory Status
RX
Drug Name
ENALAPRILAT
Product Number
1
Dosage Form
-
Strength
1.25MG/ML
Approval Date
2008-12-23
Active Ingredient
ENALAPRILAT
Application Number
78687
Product Number
1
Dosage Form
-
Strength
1.25MG/ML
Approval Date
2008-12-23
Regulatory Status
RX
Drug Name
EPHEDRINE SULFATE
Product Number
1
Dosage Form
-
Strength
50MG/ML (50MG/ML)
Approval Date
2020-12-15
Active Ingredient
EPHEDRINE SULFATE
Application Number
214334
Product Number
1
Dosage Form
-
Strength
50MG/ML (50MG/ML)
Approval Date
2020-12-15
Regulatory Status
RX
Drug Name
EPHEDRINE SULFATE
Product Number
1
Dosage Form
-
Strength
25MG/5ML (5MG/ML)
Approval Date
2024-10-11
Active Ingredient
EPHEDRINE SULFATE
Application Number
217721
Product Number
1
Dosage Form
-
Strength
25MG/5ML (5MG/ML)
Approval Date
2024-10-11
Regulatory Status
RX
Drug Name
EPINEPHRINE
Product Number
1
Dosage Form
-
Strength
1MG/ML (1MG/ML)
Approval Date
2026-05-29
Active Ingredient
EPINEPHRINE
Application Number
220562
Product Number
1
Dosage Form
-
Strength
1MG/ML (1MG/ML)
Approval Date
2026-05-29
Regulatory Status
RX
Drug Name
EPIRUBICIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
50MG/25ML (2MG/ML)
Approval Date
2007-06-27
Active Ingredient
EPIRUBICIN HYDROCHLORIDE
Application Number
65289
Product Number
1
Dosage Form
-
Strength
50MG/25ML (2MG/ML)
Approval Date
2007-06-27
Regulatory Status
RX
Drug Name
EPIRUBICIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
200MG/100ML (2MG/ML)
Approval Date
2007-06-27
Active Ingredient
EPIRUBICIN HYDROCHLORIDE
Application Number
65289
Product Number
2
Dosage Form
-
Strength
200MG/100ML (2MG/ML)
Approval Date
2007-06-27
Regulatory Status
RX
Drug Name
ESMOLOL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2004-08-10
Active Ingredient
ESMOLOL HYDROCHLORIDE
Application Number
76323
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2004-08-10
Regulatory Status
RX
Drug Name
ESTRADIOL VALERATE
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2020-04-21
Active Ingredient
ESTRADIOL VALERATE
Application Number
203723
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2020-04-21
Regulatory Status
RX
Drug Name
ESTRADIOL VALERATE
Product Number
2
Dosage Form
-
Strength
20MG/ML
Approval Date
2020-04-21
Active Ingredient
ESTRADIOL VALERATE
Application Number
203723
Product Number
2
Dosage Form
-
Strength
20MG/ML
Approval Date
2020-04-21
Regulatory Status
RX
Drug Name
ESTRADIOL VALERATE
Product Number
3
Dosage Form
-
Strength
40MG/ML
Approval Date
2020-04-21
Active Ingredient
ESTRADIOL VALERATE
Application Number
203723
Product Number
3
Dosage Form
-
Strength
40MG/ML
Approval Date
2020-04-21
Regulatory Status
RX
Drug Name
ETOMIDATE
Product Number
1
Dosage Form
-
Strength
2MG/ML
Approval Date
1996-11-04
Active Ingredient
ETOMIDATE
Application Number
74593
Product Number
1
Dosage Form
-
Strength
2MG/ML
Approval Date
1996-11-04
Regulatory Status
RX
Drug Name
ETOMIDATE
Product Number
1
Dosage Form
-
Strength
2MG/ML
Approval Date
2016-02-25
Active Ingredient
ETOMIDATE
Application Number
202354
Product Number
1
Dosage Form
-
Strength
2MG/ML
Approval Date
2016-02-25
Regulatory Status
RX
Drug Name
ETOPOSIDE
Product Number
1
Dosage Form
-
Strength
20MG/ML
Approval Date
1995-07-17
Active Ingredient
ETOPOSIDE
Application Number
74290
Product Number
1
Dosage Form
-
Strength
20MG/ML
Approval Date
1995-07-17
Regulatory Status
RX
Drug Name
EVEROLIMUS
Product Number
1
Dosage Form
-
Strength
0.25MG
Approval Date
2018-04-12
Active Ingredient
EVEROLIMUS
Application Number
206133
Product Number
1
Dosage Form
-
Strength
0.25MG
Approval Date
2018-04-12
Regulatory Status
RX
Drug Name
EVEROLIMUS
Product Number
2
Dosage Form
-
Strength
0.5MG
Approval Date
2018-04-12
Active Ingredient
EVEROLIMUS
Application Number
206133
Product Number
2
Dosage Form
-
Strength
0.5MG
Approval Date
2018-04-12
Regulatory Status
RX
Drug Name
EVEROLIMUS
Product Number
3
Dosage Form
-
Strength
0.75MG
Approval Date
2018-04-12
Active Ingredient
EVEROLIMUS
Application Number
206133
Product Number
3
Dosage Form
-
Strength
0.75MG
Approval Date
2018-04-12
Regulatory Status
RX
Drug Name
EVEROLIMUS
Product Number
4
Dosage Form
-
Strength
1MG
Approval Date
2021-11-18
Active Ingredient
EVEROLIMUS
Application Number
206133
Product Number
4
Dosage Form
-
Strength
1MG
Approval Date
2021-11-18
Regulatory Status
RX
Drug Name
EVEROLIMUS
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2020-06-08
Active Ingredient
EVEROLIMUS
Application Number
207486
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2020-06-08
Regulatory Status
RX
Drug Name
EVEROLIMUS
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2020-06-08
Active Ingredient
EVEROLIMUS
Application Number
207486
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2020-06-08
Regulatory Status
RX
Drug Name
EVEROLIMUS
Product Number
3
Dosage Form
-
Strength
7.5MG
Approval Date
2020-06-08
Active Ingredient
EVEROLIMUS
Application Number
207486
Product Number
3
Dosage Form
-
Strength
7.5MG
Approval Date
2020-06-08
Regulatory Status
RX
Drug Name
EVEROLIMUS
Product Number
4
Dosage Form
-
Strength
10MG
Approval Date
2021-11-23
Active Ingredient
EVEROLIMUS
Application Number
207486
Product Number
4
Dosage Form
-
Strength
10MG
Approval Date
2021-11-23
Regulatory Status
RX
Drug Name
FAMOTIDINE
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2001-04-16
Active Ingredient
FAMOTIDINE
Application Number
75488
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2001-04-16
Regulatory Status
RX
Drug Name
FAMOTIDINE PRESERVATIVE FREE
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2001-04-16
Active Ingredient
FAMOTIDINE
Application Number
75486
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2001-04-16
Regulatory Status
RX
Drug Name
FEBUXOSTAT
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
2019-10-15
Active Ingredient
FEBUXOSTAT
Application Number
205414
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
2019-10-15
Regulatory Status
RX
Drug Name
FEBUXOSTAT
Product Number
2
Dosage Form
-
Strength
80MG
Approval Date
2019-10-15
Active Ingredient
FEBUXOSTAT
Application Number
205414
Product Number
2
Dosage Form
-
Strength
80MG
Approval Date
2019-10-15
Regulatory Status
RX
Drug Name
FENTANYL CITRATE
Product Number
1
Dosage Form
-
Strength
EQ 0.05MG BASE/ML
Approval Date
1984-07-11
Active Ingredient
FENTANYL CITRATE
Application Number
19101
Product Number
1
Dosage Form
-
Strength
EQ 0.05MG BASE/ML
Approval Date
1984-07-11
Regulatory Status
RX
Drug Name
FENTANYL CITRATE
Product Number
2
Dosage Form
-
Strength
EQ 0.025MG BASE/0.5ML
Approval Date
2023-01-20
Active Ingredient
FENTANYL CITRATE
Application Number
19101
Product Number
2
Dosage Form
-
Strength
EQ 0.025MG BASE/0.5ML
Approval Date
2023-01-20
Regulatory Status
RX
Drug Name
FLECAINIDE ACETATE
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2003-01-14
Active Ingredient
FLECAINIDE ACETATE
Application Number
76278
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2003-01-14
Regulatory Status
RX
Drug Name
FLECAINIDE ACETATE
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2003-01-14
Active Ingredient
FLECAINIDE ACETATE
Application Number
76278
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2003-01-14
Regulatory Status
RX
Drug Name
FLECAINIDE ACETATE
Product Number
3
Dosage Form
-
Strength
150MG
Approval Date
2003-01-14
Active Ingredient
FLECAINIDE ACETATE
Application Number
76278
Product Number
3
Dosage Form
-
Strength
150MG
Approval Date
2003-01-14
Regulatory Status
RX
Drug Name
FLOXURIDINE
Product Number
1
Dosage Form
-
Strength
500MG/VIAL
Approval Date
2000-04-16
Active Ingredient
FLOXURIDINE
Application Number
75387
Product Number
1
Dosage Form
-
Strength
500MG/VIAL
Approval Date
2000-04-16
Regulatory Status
RX
Drug Name
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
Product Number
1
Dosage Form
-
Strength
200MG/100ML (2MG/ML)
Approval Date
2004-07-29
Active Ingredient
FLUCONAZOLE
Application Number
76087
Product Number
1
Dosage Form
-
Strength
200MG/100ML (2MG/ML)
Approval Date
2004-07-29
Regulatory Status
RX
Drug Name
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
Product Number
2
Dosage Form
-
Strength
100MG/50ML (2MG/ML)
Approval Date
2008-09-26
Active Ingredient
FLUCONAZOLE
Application Number
76087
Product Number
2
Dosage Form
-
Strength
100MG/50ML (2MG/ML)
Approval Date
2008-09-26
Regulatory Status
RX
Drug Name
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
Product Number
3
Dosage Form
-
Strength
400MG/200ML (2MG/ML)
Approval Date
2004-07-29
Active Ingredient
FLUCONAZOLE
Application Number
76087
Product Number
3
Dosage Form
-
Strength
400MG/200ML (2MG/ML)
Approval Date
2004-07-29
Regulatory Status
RX
Drug Name
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
Product Number
1
Dosage Form
-
Strength
200MG/100ML (2MG/ML)
Approval Date
2005-08-23
Active Ingredient
FLUCONAZOLE
Application Number
76736
Product Number
1
Dosage Form
-
Strength
200MG/100ML (2MG/ML)
Approval Date
2005-08-23
Regulatory Status
RX
Drug Name
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Product Number
1
Dosage Form
-
Strength
200MG/100ML (2MG/ML)
Approval Date
2008-07-30
Active Ingredient
FLUCONAZOLE
Application Number
78107
Product Number
1
Dosage Form
-
Strength
200MG/100ML (2MG/ML)
Approval Date
2008-07-30
Regulatory Status
RX
Drug Name
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Product Number
2
Dosage Form
-
Strength
400MG/200ML (2MG/ML)
Approval Date
2008-07-30
Active Ingredient
FLUCONAZOLE
Application Number
78107
Product Number
2
Dosage Form
-
Strength
400MG/200ML (2MG/ML)
Approval Date
2008-07-30
Regulatory Status
RX
Drug Name
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Product Number
1
Dosage Form
-
Strength
200MG/100ML (2MG/ML)
Approval Date
2012-01-30
Active Ingredient
FLUCONAZOLE
Application Number
78698
Product Number
1
Dosage Form
-
Strength
200MG/100ML (2MG/ML)
Approval Date
2012-01-30
Regulatory Status
RX
Drug Name
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Product Number
2
Dosage Form
-
Strength
400MG/200ML (2MG/ML)
Approval Date
2012-01-30
Active Ingredient
FLUCONAZOLE
Application Number
78698
Product Number
2
Dosage Form
-
Strength
400MG/200ML (2MG/ML)
Approval Date
2012-01-30
Regulatory Status
RX
Drug Name
FLUDARABINE PHOSPHATE
Product Number
1
Dosage Form
-
Strength
50MG/VIAL
Approval Date
2003-08-28
Active Ingredient
FLUDARABINE PHOSPHATE
Application Number
76349
Product Number
1
Dosage Form
-
Strength
50MG/VIAL
Approval Date
2003-08-28
Regulatory Status
RX
Drug Name
FLUMAZENIL
Product Number
1
Dosage Form
-
Strength
1MG/10ML (0.1MG/ML)
Approval Date
2004-10-12
Active Ingredient
FLUMAZENIL
Application Number
76256
Product Number
1
Dosage Form
-
Strength
1MG/10ML (0.1MG/ML)
Approval Date
2004-10-12
Regulatory Status
RX
Drug Name
FLUMAZENIL
Product Number
2
Dosage Form
-
Strength
0.5MG/5ML (0.1MG/ML)
Approval Date
2004-10-12
Active Ingredient
FLUMAZENIL
Application Number
76256
Product Number
2
Dosage Form
-
Strength
0.5MG/5ML (0.1MG/ML)
Approval Date
2004-10-12
Regulatory Status
RX
Drug Name
FLUMAZENIL
Product Number
1
Dosage Form
-
Strength
0.5MG/5ML (0.1MG/ML)
Approval Date
2009-03-23
Active Ingredient
FLUMAZENIL
Application Number
78527
Product Number
1
Dosage Form
-
Strength
0.5MG/5ML (0.1MG/ML)
Approval Date
2009-03-23
Regulatory Status
RX
Drug Name
FLUMAZENIL
Product Number
2
Dosage Form
-
Strength
1MG/10ML (0.1MG/ML)
Approval Date
2009-03-23
Active Ingredient
FLUMAZENIL
Application Number
78527
Product Number
2
Dosage Form
-
Strength
1MG/10ML (0.1MG/ML)
Approval Date
2009-03-23
Regulatory Status
RX
Drug Name
FLUPHENAZINE DECANOATE
Product Number
1
Dosage Form
-
Strength
25MG/ML
Approval Date
1996-08-30
Active Ingredient
FLUPHENAZINE DECANOATE
Application Number
74531
Product Number
1
Dosage Form
-
Strength
25MG/ML
Approval Date
1996-08-30
Regulatory Status
RX
Drug Name
FLUTICASONE PROPIONATE
Product Number
1
Dosage Form
-
Strength
0.05MG/SPRAY
Approval Date
2006-02-22
Active Ingredient
FLUTICASONE PROPIONATE
Application Number
76504
Product Number
1
Dosage Form
-
Strength
0.05MG/SPRAY
Approval Date
2006-02-22
Regulatory Status
RX
Drug Name
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE
Product Number
1
Dosage Form
-
Strength
0.1MG/INH;EQ 0.05MG BASE/INH
Approval Date
2020-12-17
Active Ingredient
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Application Number
203433
Product Number
1
Dosage Form
-
Strength
0.1MG/INH;EQ 0.05MG BASE/INH
Approval Date
2020-12-17
Regulatory Status
RX
Drug Name
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE
Product Number
2
Dosage Form
-
Strength
0.25MG/INH;EQ 0.05MG BASE/INH
Approval Date
2020-12-17
Active Ingredient
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Application Number
203433
Product Number
2
Dosage Form
-
Strength
0.25MG/INH;EQ 0.05MG BASE/INH
Approval Date
2020-12-17
Regulatory Status
RX
Drug Name
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE
Product Number
3
Dosage Form
-
Strength
0.5MG/INH;EQ 0.05MG BASE/INH
Approval Date
2023-12-19
Active Ingredient
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Application Number
203433
Product Number
3
Dosage Form
-
Strength
0.5MG/INH;EQ 0.05MG BASE/INH
Approval Date
2023-12-19
Regulatory Status
RX
Drug Name
FOSPHENYTOIN SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 50MG PHENYTOIN NA/ML
Approval Date
2007-08-06
Active Ingredient
FOSPHENYTOIN SODIUM
Application Number
77481
Product Number
1
Dosage Form
-
Strength
EQ 50MG PHENYTOIN NA/ML
Approval Date
2007-08-06
Regulatory Status
RX
Drug Name
FOSPHENYTOIN SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 50MG PHENYTOIN NA/ML
Approval Date
2007-08-06
Active Ingredient
FOSPHENYTOIN SODIUM
Application Number
77989
Product Number
1
Dosage Form
-
Strength
EQ 50MG PHENYTOIN NA/ML
Approval Date
2007-08-06
Regulatory Status
RX
Drug Name
FOSPHENYTOIN SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 50MG PHENYTOIN NA/ML
Approval Date
2009-12-02
Active Ingredient
FOSPHENYTOIN SODIUM
Application Number
78765
Product Number
1
Dosage Form
-
Strength
EQ 50MG PHENYTOIN NA/ML
Approval Date
2009-12-02
Regulatory Status
RX
Drug Name
FUROSEMIDE
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
1982-01-01
Active Ingredient
FUROSEMIDE
Application Number
18267
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
FUROSEMIDE
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
1983-11-10
Active Ingredient
FUROSEMIDE
Application Number
18823
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
1983-11-10
Regulatory Status
RX
Drug Name
FUROSEMIDE
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
1983-11-10
Active Ingredient
FUROSEMIDE
Application Number
18823
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
1983-11-10
Regulatory Status
RX
Drug Name
FUROSEMIDE
Product Number
1
Dosage Form
-
Strength
80MG
Approval Date
1986-01-24
Active Ingredient
FUROSEMIDE
Application Number
70086
Product Number
1
Dosage Form
-
Strength
80MG
Approval Date
1986-01-24
Regulatory Status
RX
Drug Name
FUROSEMIDE
Product Number
1
Dosage Form
-
Strength
40MG/5ML
Approval Date
1987-04-22
Active Ingredient
FUROSEMIDE
Application Number
70433
Product Number
1
Dosage Form
-
Strength
40MG/5ML
Approval Date
1987-04-22
Regulatory Status
RX
Drug Name
FUROSEMIDE
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
1987-04-22
Active Ingredient
FUROSEMIDE
Application Number
70434
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
1987-04-22
Regulatory Status
RX
Drug Name
GALANTAMINE HYDROBROMIDE
Product Number
1
Dosage Form
-
Strength
4MG/ML
Approval Date
2009-01-30
Active Ingredient
GALANTAMINE HYDROBROMIDE
Application Number
78185
Product Number
1
Dosage Form
-
Strength
4MG/ML
Approval Date
2009-01-30
Regulatory Status
RX
Drug Name
GANCICLOVIR SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2003-07-16
Active Ingredient
GANCICLOVIR SODIUM
Application Number
76222
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2003-07-16
Regulatory Status
RX
Drug Name
GEMCITABINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
200MG/5.26ML (38MG/ML)
Approval Date
2023-03-07
Active Ingredient
GEMCITABINE HYDROCHLORIDE
Application Number
213175
Product Number
1
Dosage Form
-
Strength
200MG/5.26ML (38MG/ML)
Approval Date
2023-03-07
Regulatory Status
RX
Drug Name
GEMCITABINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
1GM/26.3ML (38MG/ML)
Approval Date
2023-03-07
Active Ingredient
GEMCITABINE HYDROCHLORIDE
Application Number
213175
Product Number
2
Dosage Form
-
Strength
1GM/26.3ML (38MG/ML)
Approval Date
2023-03-07
Regulatory Status
RX
Drug Name
GEMCITABINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
2GM/52.6ML (38MG/ML)
Approval Date
2023-03-07
Active Ingredient
GEMCITABINE HYDROCHLORIDE
Application Number
213175
Product Number
3
Dosage Form
-
Strength
2GM/52.6ML (38MG/ML)
Approval Date
2023-03-07
Regulatory Status
RX
Drug Name
GENTAMICIN SULFATE
Product Number
1
Dosage Form
-
Strength
EQ 40MG BASE/ML
Approval Date
1982-01-01
Active Ingredient
GENTAMICIN SULFATE
Application Number
62251
Product Number
1
Dosage Form
-
Strength
EQ 40MG BASE/ML
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
GENTAMICIN SULFATE
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE/ML
Approval Date
1982-01-01
Active Ingredient
GENTAMICIN SULFATE
Application Number
62251
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE/ML
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
GLYCOPYRROLATE
Product Number
1
Dosage Form
-
Strength
0.2MG/ML
Approval Date
2011-09-21
Active Ingredient
GLYCOPYRROLATE
Application Number
90963
Product Number
1
Dosage Form
-
Strength
0.2MG/ML
Approval Date
2011-09-21
Regulatory Status
RX
Drug Name
GRANISETRON HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
Approval Date
2007-12-31
Active Ingredient
GRANISETRON HYDROCHLORIDE
Application Number
77177
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
Approval Date
2007-12-31
Regulatory Status
RX
Drug Name
GRANISETRON HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
Approval Date
2008-06-30
Active Ingredient
GRANISETRON HYDROCHLORIDE
Application Number
77186
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
Approval Date
2008-06-30
Regulatory Status
RX
Drug Name
GRANISETRON HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/ML (EQ 1MG BASE/ML)
Approval Date
2008-06-30
Active Ingredient
GRANISETRON HYDROCHLORIDE
Application Number
77187
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/ML (EQ 1MG BASE/ML)
Approval Date
2008-06-30
Regulatory Status
RX
Drug Name
GRANISETRON HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)
Approval Date
2008-06-26
Active Ingredient
GRANISETRON HYDROCHLORIDE
Application Number
77913
Product Number
1
Dosage Form
-
Strength
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)
Approval Date
2008-06-26
Regulatory Status
RX
Drug Name
GRANISETRON HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/ML (EQ 1MG BASE/ML)
Approval Date
2009-12-23
Active Ingredient
GRANISETRON HYDROCHLORIDE
Application Number
78629
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/ML (EQ 1MG BASE/ML)
Approval Date
2009-12-23
Regulatory Status
RX
Drug Name
GRANISETRON HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
Approval Date
2009-12-23
Active Ingredient
GRANISETRON HYDROCHLORIDE
Application Number
78629
Product Number
2
Dosage Form
-
Strength
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
Approval Date
2009-12-23
Regulatory Status
RX
Drug Name
HALOPERIDOL
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/ML
Approval Date
2001-06-18
Active Ingredient
HALOPERIDOL LACTATE
Application Number
75858
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/ML
Approval Date
2001-06-18
Regulatory Status
RX
Drug Name
HALOPERIDOL DECANOATE
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE/ML
Approval Date
1998-09-28
Active Ingredient
HALOPERIDOL DECANOATE
Application Number
75305
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE/ML
Approval Date
1998-09-28
Regulatory Status
RX
Drug Name
HEPARIN SODIUM
Product Number
1
Dosage Form
-
Strength
1,000 UNITS/ML
Approval Date
1982-01-01
Active Ingredient
HEPARIN SODIUM
Application Number
17037
Product Number
1
Dosage Form
-
Strength
1,000 UNITS/ML
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
HEPARIN SODIUM
Product Number
2
Dosage Form
-
Strength
5,000 UNITS/ML
Approval Date
1982-01-01
Active Ingredient
HEPARIN SODIUM
Application Number
17037
Product Number
2
Dosage Form
-
Strength
5,000 UNITS/ML
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
HEPARIN SODIUM
Product Number
3
Dosage Form
-
Strength
10,000 UNITS/ML
Approval Date
1982-01-01
Active Ingredient
HEPARIN SODIUM
Application Number
17037
Product Number
3
Dosage Form
-
Strength
10,000 UNITS/ML
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
HEPARIN SODIUM
Product Number
13
Dosage Form
-
Strength
5,000 UNITS/0.5ML
Approval Date
1986-04-07
Active Ingredient
HEPARIN SODIUM
Application Number
17037
Product Number
13
Dosage Form
-
Strength
5,000 UNITS/0.5ML
Approval Date
1986-04-07
Regulatory Status
RX
Drug Name
HYDRALAZINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
20MG/ML
Approval Date
2020-12-18
Active Ingredient
HYDRALAZINE HYDROCHLORIDE
Application Number
213667
Product Number
1
Dosage Form
-
Strength
20MG/ML
Approval Date
2020-12-18
Regulatory Status
RX
Drug Name
HYDROMORPHONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
5MG/5ML
Approval Date
1998-07-29
Active Ingredient
HYDROMORPHONE HYDROCHLORIDE
Application Number
74653
Product Number
1
Dosage Form
-
Strength
5MG/5ML
Approval Date
1998-07-29
Regulatory Status
RX
Drug Name
HYDROMORPHONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
2MG/ML
Approval Date
2018-04-27
Active Ingredient
HYDROMORPHONE HYDROCHLORIDE
Application Number
202159
Product Number
1
Dosage Form
-
Strength
2MG/ML
Approval Date
2018-04-27
Regulatory Status
RX
Drug Name
HYDROMORPHONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
0.2MG/ML
Approval Date
2024-02-09
Active Ingredient
HYDROMORPHONE HYDROCHLORIDE
Application Number
216899
Product Number
1
Dosage Form
-
Strength
0.2MG/ML
Approval Date
2024-02-09
Regulatory Status
RX
Drug Name
HYDROMORPHONE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
0.5MG/0.5ML
Approval Date
2024-02-09
Active Ingredient
HYDROMORPHONE HYDROCHLORIDE
Application Number
216899
Product Number
2
Dosage Form
-
Strength
0.5MG/0.5ML
Approval Date
2024-02-09
Regulatory Status
RX
Drug Name
HYDROMORPHONE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
1MG/ML
Approval Date
2024-02-09
Active Ingredient
HYDROMORPHONE HYDROCHLORIDE
Application Number
216899
Product Number
3
Dosage Form
-
Strength
1MG/ML
Approval Date
2024-02-09
Regulatory Status
RX
Drug Name
HYDROMORPHONE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
2MG/ML
Approval Date
2024-02-09
Active Ingredient
HYDROMORPHONE HYDROCHLORIDE
Application Number
216899
Product Number
4
Dosage Form
-
Strength
2MG/ML
Approval Date
2024-02-09
Regulatory Status
RX
Drug Name
HYDROMORPHONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
40MG/20ML (2MG/ML)
Approval Date
2023-12-14
Active Ingredient
HYDROMORPHONE HYDROCHLORIDE
Application Number
217812
Product Number
1
Dosage Form
-
Strength
40MG/20ML (2MG/ML)
Approval Date
2023-12-14
Regulatory Status
RX
Drug Name
ICOSAPENT ETHYL
Product Number
1
Dosage Form
-
Strength
1GM
Approval Date
2020-05-21
Active Ingredient
ICOSAPENT ETHYL
Application Number
209457
Product Number
1
Dosage Form
-
Strength
1GM
Approval Date
2020-05-21
Regulatory Status
RX
Drug Name
ICOSAPENT ETHYL
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2023-03-08
Active Ingredient
ICOSAPENT ETHYL
Application Number
209457
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2023-03-08
Regulatory Status
RX
Drug Name
IDARUBICIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
5MG/5ML (1MG/ML)
Approval Date
2006-12-14
Active Ingredient
IDARUBICIN HYDROCHLORIDE
Application Number
65275
Product Number
1
Dosage Form
-
Strength
5MG/5ML (1MG/ML)
Approval Date
2006-12-14
Regulatory Status
RX
Drug Name
IDARUBICIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
10MG/10ML (1MG/ML)
Approval Date
2006-12-14
Active Ingredient
IDARUBICIN HYDROCHLORIDE
Application Number
65275
Product Number
2
Dosage Form
-
Strength
10MG/10ML (1MG/ML)
Approval Date
2006-12-14
Regulatory Status
RX
Drug Name
IDARUBICIN HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
20MG/20ML (1MG/ML)
Approval Date
2006-12-14
Active Ingredient
IDARUBICIN HYDROCHLORIDE
Application Number
65275
Product Number
3
Dosage Form
-
Strength
20MG/20ML (1MG/ML)
Approval Date
2006-12-14
Regulatory Status
RX
Drug Name
IDARUBICIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
5MG/5ML (1MG/ML)
Approval Date
2007-05-15
Active Ingredient
IDARUBICIN HYDROCHLORIDE
Application Number
65288
Product Number
1
Dosage Form
-
Strength
5MG/5ML (1MG/ML)
Approval Date
2007-05-15
Regulatory Status
RX
Drug Name
IDARUBICIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
10MG/10ML (1MG/ML)
Approval Date
2007-05-15
Active Ingredient
IDARUBICIN HYDROCHLORIDE
Application Number
65288
Product Number
2
Dosage Form
-
Strength
10MG/10ML (1MG/ML)
Approval Date
2007-05-15
Regulatory Status
RX
Drug Name
IDARUBICIN HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
20MG/20ML (1MG/ML)
Approval Date
2007-05-15
Active Ingredient
IDARUBICIN HYDROCHLORIDE
Application Number
65288
Product Number
3
Dosage Form
-
Strength
20MG/20ML (1MG/ML)
Approval Date
2007-05-15
Regulatory Status
RX
Drug Name
IFOSFAMIDE
Product Number
1
Dosage Form
-
Strength
1GM/20ML (50MG/ML)
Approval Date
2011-06-29
Active Ingredient
IFOSFAMIDE
Application Number
76619
Product Number
1
Dosage Form
-
Strength
1GM/20ML (50MG/ML)
Approval Date
2011-06-29
Regulatory Status
RX
Drug Name
IFOSFAMIDE
Product Number
2
Dosage Form
-
Strength
3GM/60ML (50MG/ML)
Approval Date
2011-06-29
Active Ingredient
IFOSFAMIDE
Application Number
76619
Product Number
2
Dosage Form
-
Strength
3GM/60ML (50MG/ML)
Approval Date
2011-06-29
Regulatory Status
RX
Drug Name
IMIPRAMINE PAMOATE
Product Number
1
Dosage Form
-
Strength
EQ 75MG HYDROCHLORIDE
Approval Date
2010-04-16
Active Ingredient
IMIPRAMINE PAMOATE
Application Number
91099
Product Number
1
Dosage Form
-
Strength
EQ 75MG HYDROCHLORIDE
Approval Date
2010-04-16
Regulatory Status
RX
Drug Name
IMIPRAMINE PAMOATE
Product Number
2
Dosage Form
-
Strength
EQ 100MG HYDROCHLORIDE
Approval Date
2010-04-16
Active Ingredient
IMIPRAMINE PAMOATE
Application Number
91099
Product Number
2
Dosage Form
-
Strength
EQ 100MG HYDROCHLORIDE
Approval Date
2010-04-16
Regulatory Status
RX
Drug Name
IMIPRAMINE PAMOATE
Product Number
3
Dosage Form
-
Strength
EQ 125MG HYDROCHLORIDE
Approval Date
2010-04-16
Active Ingredient
IMIPRAMINE PAMOATE
Application Number
91099
Product Number
3
Dosage Form
-
Strength
EQ 125MG HYDROCHLORIDE
Approval Date
2010-04-16
Regulatory Status
RX
Drug Name
IMIPRAMINE PAMOATE
Product Number
4
Dosage Form
-
Strength
EQ 150MG HYDROCHLORIDE
Approval Date
2010-04-16
Active Ingredient
IMIPRAMINE PAMOATE
Application Number
91099
Product Number
4
Dosage Form
-
Strength
EQ 150MG HYDROCHLORIDE
Approval Date
2010-04-16
Regulatory Status
RX
Drug Name
IMMPHENTIV
Product Number
4
Dosage Form
-
Strength
0.5MG/5ML (0.1MG/ML)
Approval Date
2023-03-09
Active Ingredient
PHENYLEPHRINE HYDROCHLORIDE
Application Number
203826
Product Number
4
Dosage Form
-
Strength
0.5MG/5ML (0.1MG/ML)
Approval Date
2023-03-09
Regulatory Status
RX
Drug Name
IMMPHENTIV
Product Number
5
Dosage Form
-
Strength
1MG/10ML (0.1MG/ML)
Approval Date
2023-03-09
Active Ingredient
PHENYLEPHRINE HYDROCHLORIDE
Application Number
203826
Product Number
5
Dosage Form
-
Strength
1MG/10ML (0.1MG/ML)
Approval Date
2023-03-09
Regulatory Status
RX
Drug Name
INDOMETHACIN
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2024-11-19
Active Ingredient
INDOMETHACIN
Application Number
215899
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2024-11-19
Regulatory Status
RX
Drug Name
INFUMORPH
Product Number
3
Dosage Form
-
Strength
10MG/ML
Approval Date
1991-07-19
Active Ingredient
MORPHINE SULFATE
Application Number
18565
Product Number
3
Dosage Form
-
Strength
10MG/ML
Approval Date
1991-07-19
Regulatory Status
RX
Drug Name
INFUMORPH
Product Number
4
Dosage Form
-
Strength
25MG/ML
Approval Date
1991-07-19
Active Ingredient
MORPHINE SULFATE
Application Number
18565
Product Number
4
Dosage Form
-
Strength
25MG/ML
Approval Date
1991-07-19
Regulatory Status
RX
Drug Name
IPRATROPIUM BROMIDE
Product Number
1
Dosage Form
-
Strength
0.042MG/SPRAY
Approval Date
2003-11-05
Active Ingredient
IPRATROPIUM BROMIDE
Application Number
76598
Product Number
1
Dosage Form
-
Strength
0.042MG/SPRAY
Approval Date
2003-11-05
Regulatory Status
RX
Drug Name
IPRATROPIUM BROMIDE
Product Number
1
Dosage Form
-
Strength
0.021MG/SPRAY
Approval Date
2003-11-05
Active Ingredient
IPRATROPIUM BROMIDE
Application Number
76664
Product Number
1
Dosage Form
-
Strength
0.021MG/SPRAY
Approval Date
2003-11-05
Regulatory Status
RX
Drug Name
IRINOTECAN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
40MG/2ML (20MG/ML)
Approval Date
2008-12-24
Active Ingredient
IRINOTECAN HYDROCHLORIDE
Application Number
78753
Product Number
1
Dosage Form
-
Strength
40MG/2ML (20MG/ML)
Approval Date
2008-12-24
Regulatory Status
RX
Drug Name
IRINOTECAN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
100MG/5ML (20MG/ML)
Approval Date
2008-12-24
Active Ingredient
IRINOTECAN HYDROCHLORIDE
Application Number
78753
Product Number
2
Dosage Form
-
Strength
100MG/5ML (20MG/ML)
Approval Date
2008-12-24
Regulatory Status
RX
Drug Name
IRINOTECAN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
40MG/2ML (20MG/ML)
Approval Date
2010-12-20
Active Ingredient
IRINOTECAN HYDROCHLORIDE
Application Number
91032
Product Number
1
Dosage Form
-
Strength
40MG/2ML (20MG/ML)
Approval Date
2010-12-20
Regulatory Status
RX
Drug Name
IRINOTECAN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
100MG/5ML (20MG/ML)
Approval Date
2010-12-20
Active Ingredient
IRINOTECAN HYDROCHLORIDE
Application Number
91032
Product Number
2
Dosage Form
-
Strength
100MG/5ML (20MG/ML)
Approval Date
2010-12-20
Regulatory Status
RX
Drug Name
ISOPROTERENOL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
0.2MG/ML
Approval Date
2023-04-26
Active Ingredient
ISOPROTERENOL HYDROCHLORIDE
Application Number
211703
Product Number
1
Dosage Form
-
Strength
0.2MG/ML
Approval Date
2023-04-26
Regulatory Status
RX
Drug Name
ISOSORBIDE DINITRATE
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
1987-11-02
Active Ingredient
ISOSORBIDE DINITRATE
Application Number
88088
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
1987-11-02
Regulatory Status
RX
Drug Name
ISOSORBIDE DINITRATE
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
1987-10-29
Active Ingredient
ISOSORBIDE DINITRATE
Application Number
88088
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
1987-10-29
Regulatory Status
RX
Drug Name
ISOSORBIDE DINITRATE
Product Number
3
Dosage Form
-
Strength
5MG
Approval Date
1987-10-29
Active Ingredient
ISOSORBIDE DINITRATE
Application Number
88088
Product Number
3
Dosage Form
-
Strength
5MG
Approval Date
1987-10-29
Regulatory Status
RX
Drug Name
KETAMINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/ML
Approval Date
1996-03-22
Active Ingredient
KETAMINE HYDROCHLORIDE
Application Number
74524
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/ML
Approval Date
1996-03-22
Regulatory Status
RX
Drug Name
KETAMINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE/ML
Approval Date
1996-03-22
Active Ingredient
KETAMINE HYDROCHLORIDE
Application Number
74524
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE/ML
Approval Date
1996-03-22
Regulatory Status
RX
Drug Name
KETOROLAC TROMETHAMINE
Product Number
1
Dosage Form
-
Strength
15MG/ML
Approval Date
2004-07-21
Active Ingredient
KETOROLAC TROMETHAMINE
Application Number
75772
Product Number
1
Dosage Form
-
Strength
15MG/ML
Approval Date
2004-07-21
Regulatory Status
RX
Drug Name
KETOROLAC TROMETHAMINE
Product Number
2
Dosage Form
-
Strength
30MG/ML
Approval Date
2004-07-21
Active Ingredient
KETOROLAC TROMETHAMINE
Application Number
75772
Product Number
2
Dosage Form
-
Strength
30MG/ML
Approval Date
2004-07-21
Regulatory Status
RX
Drug Name
KLOXXADO
Product Number
1
Dosage Form
-
Strength
8MG/SPRAY
Approval Date
2021-04-29
Active Ingredient
NALOXONE HYDROCHLORIDE
Application Number
212045
Product Number
1
Dosage Form
-
Strength
8MG/SPRAY
Approval Date
2021-04-29
Regulatory Status
RX
Drug Name
KLOXXADO
Product Number
2
Dosage Form
-
Strength
4MG/SPRAY
Approval Date
2025-08-25
Active Ingredient
NALOXONE HYDROCHLORIDE
Application Number
212045
Product Number
2
Dosage Form
-
Strength
4MG/SPRAY
Approval Date
2025-08-25
Regulatory Status
RX
Drug Name
LABETALOL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
5MG/ML
Approval Date
1999-05-28
Active Ingredient
LABETALOL HYDROCHLORIDE
Application Number
75303
Product Number
1
Dosage Form
-
Strength
5MG/ML
Approval Date
1999-05-28
Regulatory Status
RX
Drug Name
LABETALOL HYDROCHLORIDE
Product Number
6
Dosage Form
-
Strength
20MG/4ML (5MG/ML)
Approval Date
2024-08-19
Active Ingredient
LABETALOL HYDROCHLORIDE
Application Number
213330
Product Number
6
Dosage Form
-
Strength
20MG/4ML (5MG/ML)
Approval Date
2024-08-19
Regulatory Status
RX
Drug Name
LABETALOL HYDROCHLORIDE IN DEXTROSE
Product Number
1
Dosage Form
-
Strength
200MG/200ML (1MG/ML)
Approval Date
2020-11-09
Active Ingredient
LABETALOL HYDROCHLORIDE
Application Number
213330
Product Number
1
Dosage Form
-
Strength
200MG/200ML (1MG/ML)
Approval Date
2020-11-09
Regulatory Status
RX
Drug Name
LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE
Product Number
2
Dosage Form
-
Strength
100MG/100ML (1MG/ML)
Approval Date
2020-11-09
Active Ingredient
LABETALOL HYDROCHLORIDE
Application Number
213330
Product Number
2
Dosage Form
-
Strength
100MG/100ML (1MG/ML)
Approval Date
2020-11-09
Regulatory Status
RX
Drug Name
LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE
Product Number
3
Dosage Form
-
Strength
200MG/200ML (1MG/ML)
Approval Date
2020-11-09
Active Ingredient
LABETALOL HYDROCHLORIDE
Application Number
213330
Product Number
3
Dosage Form
-
Strength
200MG/200ML (1MG/ML)
Approval Date
2020-11-09
Regulatory Status
RX
Drug Name
LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE
Product Number
4
Dosage Form
-
Strength
300MG/300ML (1MG/ML)
Approval Date
2020-11-09
Active Ingredient
LABETALOL HYDROCHLORIDE
Application Number
213330
Product Number
4
Dosage Form
-
Strength
300MG/300ML (1MG/ML)
Approval Date
2020-11-09
Regulatory Status
RX
Drug Name
LACOSAMIDE
Product Number
1
Dosage Form
-
Strength
200MG/20ML (10MG/ML)
Approval Date
2024-04-05
Active Ingredient
LACOSAMIDE
Application Number
216806
Product Number
1
Dosage Form
-
Strength
200MG/20ML (10MG/ML)
Approval Date
2024-04-05
Regulatory Status
RX
Drug Name
LEUCOVORIN CALCIUM
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
1993-02-22
Active Ingredient
LEUCOVORIN CALCIUM
Application Number
72733
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
1993-02-22
Regulatory Status
RX
Drug Name
LEUCOVORIN CALCIUM
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
1993-02-22
Active Ingredient
LEUCOVORIN CALCIUM
Application Number
72734
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
1993-02-22
Regulatory Status
RX
Drug Name
LEUCOVORIN CALCIUM
Product Number
1
Dosage Form
-
Strength
EQ 15MG BASE
Approval Date
1993-02-22
Active Ingredient
LEUCOVORIN CALCIUM
Application Number
72735
Product Number
1
Dosage Form
-
Strength
EQ 15MG BASE
Approval Date
1993-02-22
Regulatory Status
RX
Drug Name
LEUCOVORIN CALCIUM
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
1993-02-22
Active Ingredient
LEUCOVORIN CALCIUM
Application Number
72736
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
1993-02-22
Regulatory Status
RX
Drug Name
LEUCOVORIN CALCIUM
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/VIAL
Approval Date
1987-09-14
Active Ingredient
LEUCOVORIN CALCIUM
Application Number
89384
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/VIAL
Approval Date
1987-09-14
Regulatory Status
RX
Drug Name
LEUCOVORIN CALCIUM
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE/VIAL
Approval Date
1988-03-28
Active Ingredient
LEUCOVORIN CALCIUM
Application Number
89717
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE/VIAL
Approval Date
1988-03-28
Regulatory Status
RX
Drug Name
LEUCOVORIN CALCIUM PRESERVATIVE FREE
Product Number
1
Dosage Form
-
Strength
EQ 200MG BASE/VIAL
Approval Date
1995-05-23
Active Ingredient
LEUCOVORIN CALCIUM
Application Number
40056
Product Number
1
Dosage Form
-
Strength
EQ 200MG BASE/VIAL
Approval Date
1995-05-23
Regulatory Status
RX
Drug Name
LEUCOVORIN CALCIUM PRESERVATIVE FREE
Product Number
1
Dosage Form
-
Strength
EQ 350MG BASE/VIAL
Approval Date
2000-04-20
Active Ingredient
LEUCOVORIN CALCIUM
Application Number
40335
Product Number
1
Dosage Form
-
Strength
EQ 350MG BASE/VIAL
Approval Date
2000-04-20
Regulatory Status
RX
Drug Name
LEVETIRACETAM
Product Number
1
Dosage Form
-
Strength
500MG/5ML (100MG/ML)
Approval Date
2011-10-13
Active Ingredient
LEVETIRACETAM
Application Number
90981
Product Number
1
Dosage Form
-
Strength
500MG/5ML (100MG/ML)
Approval Date
2011-10-13
Regulatory Status
RX
Drug Name
LEVETIRACETAM IN SODIUM CHLORIDE
Product Number
1
Dosage Form
-
Strength
500MG/100ML (5MG/ML)
Approval Date
2024-02-12
Active Ingredient
LEVETIRACETAM
Application Number
211356
Product Number
1
Dosage Form
-
Strength
500MG/100ML (5MG/ML)
Approval Date
2024-02-12
Regulatory Status
RX
Drug Name
LEVETIRACETAM IN SODIUM CHLORIDE
Product Number
2
Dosage Form
-
Strength
1GM/100ML (10MG/ML)
Approval Date
2024-02-12
Active Ingredient
LEVETIRACETAM
Application Number
211356
Product Number
2
Dosage Form
-
Strength
1GM/100ML (10MG/ML)
Approval Date
2024-02-12
Regulatory Status
RX
Drug Name
LEVETIRACETAM IN SODIUM CHLORIDE
Product Number
3
Dosage Form
-
Strength
1.5GM/100ML (15MG/ML)
Approval Date
2024-02-12
Active Ingredient
LEVETIRACETAM
Application Number
211356
Product Number
3
Dosage Form
-
Strength
1.5GM/100ML (15MG/ML)
Approval Date
2024-02-12
Regulatory Status
RX
Drug Name
LEVOCARNITINE
Product Number
1
Dosage Form
-
Strength
200MG/ML
Approval Date
2001-03-29
Active Ingredient
LEVOCARNITINE
Application Number
75567
Product Number
1
Dosage Form
-
Strength
200MG/ML
Approval Date
2001-03-29
Regulatory Status
RX
Drug Name
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Product Number
1
Dosage Form
-
Strength
EQ 250MG/50ML (EQ 5MG/ML)
Approval Date
2011-09-16
Active Ingredient
LEVOFLOXACIN
Application Number
91375
Product Number
1
Dosage Form
-
Strength
EQ 250MG/50ML (EQ 5MG/ML)
Approval Date
2011-09-16
Regulatory Status
RX
Drug Name
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Product Number
2
Dosage Form
-
Strength
EQ 500MG/100ML (EQ 5MG/ML)
Approval Date
2011-09-16
Active Ingredient
LEVOFLOXACIN
Application Number
91375
Product Number
2
Dosage Form
-
Strength
EQ 500MG/100ML (EQ 5MG/ML)
Approval Date
2011-09-16
Regulatory Status
RX
Drug Name
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Product Number
3
Dosage Form
-
Strength
EQ 750MG/150ML (EQ 5MG/ML)
Approval Date
2011-09-16
Active Ingredient
LEVOFLOXACIN
Application Number
91375
Product Number
3
Dosage Form
-
Strength
EQ 750MG/150ML (EQ 5MG/ML)
Approval Date
2011-09-16
Regulatory Status
RX
Drug Name
LEVORPHANOL TARTRATE
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
2000-03-31
Active Ingredient
LEVORPHANOL TARTRATE
Application Number
74278
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
2000-03-31
Regulatory Status
RX
Drug Name
LEVOTHYROXINE SODIUM
Product Number
1
Dosage Form
-
Strength
100MCG/ML
Approval Date
2021-05-17
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
214253
Product Number
1
Dosage Form
-
Strength
100MCG/ML
Approval Date
2021-05-17
Regulatory Status
RX
Drug Name
LIDOCAINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
4%
Approval Date
1985-04-03
Active Ingredient
LIDOCAINE HYDROCHLORIDE
Application Number
88803
Product Number
1
Dosage Form
-
Strength
4%
Approval Date
1985-04-03
Regulatory Status
RX
Drug Name
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
1982-01-01
Active Ingredient
LIDOCAINE HYDROCHLORIDE
Application Number
84625
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
Product Number
2
Dosage Form
-
Strength
2%
Approval Date
1982-01-01
Active Ingredient
LIDOCAINE HYDROCHLORIDE
Application Number
84625
Product Number
2
Dosage Form
-
Strength
2%
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
LIDOCAINE VISCOUS
Product Number
1
Dosage Form
-
Strength
2%
Approval Date
1985-04-26
Active Ingredient
LIDOCAINE HYDROCHLORIDE
Application Number
88802
Product Number
1
Dosage Form
-
Strength
2%
Approval Date
1985-04-26
Regulatory Status
RX
Drug Name
LINEZOLID
Product Number
1
Dosage Form
-
Strength
100MG/5ML
Approval Date
2015-06-03
Active Ingredient
LINEZOLID
Application Number
200068
Product Number
1
Dosage Form
-
Strength
100MG/5ML
Approval Date
2015-06-03
Regulatory Status
RX
Drug Name
LINEZOLID
Product Number
1
Dosage Form
-
Strength
600MG/300ML (2MG/ML)
Approval Date
2022-08-22
Active Ingredient
LINEZOLID
Application Number
206454
Product Number
1
Dosage Form
-
Strength
600MG/300ML (2MG/ML)
Approval Date
2022-08-22
Regulatory Status
RX
Drug Name
LIRAGLUTIDE
Product Number
1
Dosage Form
-
Strength
18MG/3ML (6MG/ML)
Approval Date
2024-12-23
Active Ingredient
LIRAGLUTIDE
Application Number
215503
Product Number
1
Dosage Form
-
Strength
18MG/3ML (6MG/ML)
Approval Date
2024-12-23
Regulatory Status
RX
Drug Name
LISDEXAMFETAMINE DIMESYLATE
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2023-08-25
Active Ingredient
LISDEXAMFETAMINE DIMESYLATE
Application Number
202827
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2023-08-25
Regulatory Status
RX
Drug Name
LISDEXAMFETAMINE DIMESYLATE
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
2023-08-25
Active Ingredient
LISDEXAMFETAMINE DIMESYLATE
Application Number
202827
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
2023-08-25
Regulatory Status
RX
Drug Name
LISDEXAMFETAMINE DIMESYLATE
Product Number
3
Dosage Form
-
Strength
40MG
Approval Date
2023-08-25
Active Ingredient
LISDEXAMFETAMINE DIMESYLATE
Application Number
202827
Product Number
3
Dosage Form
-
Strength
40MG
Approval Date
2023-08-25
Regulatory Status
RX
Drug Name
LISDEXAMFETAMINE DIMESYLATE
Product Number
4
Dosage Form
-
Strength
50MG
Approval Date
2023-08-25
Active Ingredient
LISDEXAMFETAMINE DIMESYLATE
Application Number
202827
Product Number
4
Dosage Form
-
Strength
50MG
Approval Date
2023-08-25
Regulatory Status
RX
Drug Name
LISDEXAMFETAMINE DIMESYLATE
Product Number
5
Dosage Form
-
Strength
60MG
Approval Date
2023-08-25
Active Ingredient
LISDEXAMFETAMINE DIMESYLATE
Application Number
202827
Product Number
5
Dosage Form
-
Strength
60MG
Approval Date
2023-08-25
Regulatory Status
RX
Drug Name
LISDEXAMFETAMINE DIMESYLATE
Product Number
6
Dosage Form
-
Strength
70MG
Approval Date
2023-08-25
Active Ingredient
LISDEXAMFETAMINE DIMESYLATE
Application Number
202827
Product Number
6
Dosage Form
-
Strength
70MG
Approval Date
2023-08-25
Regulatory Status
RX
Drug Name
LISDEXAMFETAMINE DIMESYLATE
Product Number
7
Dosage Form
-
Strength
10MG
Approval Date
2024-01-17
Active Ingredient
LISDEXAMFETAMINE DIMESYLATE
Application Number
202827
Product Number
7
Dosage Form
-
Strength
10MG
Approval Date
2024-01-17
Regulatory Status
RX
Drug Name
LITHIUM CARBONATE
Product Number
1
Dosage Form
-
Strength
300MG
Approval Date
1982-01-01
Active Ingredient
LITHIUM CARBONATE
Application Number
17812
Product Number
1
Dosage Form
-
Strength
300MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
LITHIUM CARBONATE
Product Number
2
Dosage Form
-
Strength
150MG
Approval Date
1987-01-28
Active Ingredient
LITHIUM CARBONATE
Application Number
17812
Product Number
2
Dosage Form
-
Strength
150MG
Approval Date
1987-01-28
Regulatory Status
RX
Drug Name
LITHIUM CARBONATE
Product Number
3
Dosage Form
-
Strength
600MG
Approval Date
1987-01-28
Active Ingredient
LITHIUM CARBONATE
Application Number
17812
Product Number
3
Dosage Form
-
Strength
600MG
Approval Date
1987-01-28
Regulatory Status
RX
Drug Name
LITHIUM CARBONATE
Product Number
1
Dosage Form
-
Strength
300MG
Approval Date
1982-01-29
Active Ingredient
LITHIUM CARBONATE
Application Number
18558
Product Number
1
Dosage Form
-
Strength
300MG
Approval Date
1982-01-29
Regulatory Status
RX
Drug Name
LITHIUM CARBONATE
Product Number
1
Dosage Form
-
Strength
450MG
Approval Date
2004-01-05
Active Ingredient
LITHIUM CARBONATE
Application Number
76691
Product Number
1
Dosage Form
-
Strength
450MG
Approval Date
2004-01-05
Regulatory Status
RX
Drug Name
LITHIUM CARBONATE
Product Number
1
Dosage Form
-
Strength
300MG
Approval Date
2004-10-28
Active Ingredient
LITHIUM CARBONATE
Application Number
76832
Product Number
1
Dosage Form
-
Strength
300MG
Approval Date
2004-10-28
Regulatory Status
RX
Drug Name
LORAZEPAM INTENSOL
Product Number
1
Dosage Form
-
Strength
2MG/ML
Approval Date
1991-06-28
Active Ingredient
LORAZEPAM
Application Number
72755
Product Number
1
Dosage Form
-
Strength
2MG/ML
Approval Date
1991-06-28
Regulatory Status
RX
Drug Name
MELPHALAN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/VIAL
Approval Date
2010-10-28
Active Ingredient
MELPHALAN HYDROCHLORIDE
Application Number
90303
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/VIAL
Approval Date
2010-10-28
Regulatory Status
RX
Drug Name
MEPERIDINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
50MG/5ML
Approval Date
1985-01-30
Active Ingredient
MEPERIDINE HYDROCHLORIDE
Application Number
88744
Product Number
1
Dosage Form
-
Strength
50MG/5ML
Approval Date
1985-01-30
Regulatory Status
RX
Drug Name
MERCAPTOPURINE
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2004-02-13
Active Ingredient
MERCAPTOPURINE
Application Number
40528
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2004-02-13
Regulatory Status
RX
Drug Name
MERCAPTOPURINE
Product Number
1
Dosage Form
-
Strength
20MG/ML
Approval Date
2025-02-26
Active Ingredient
MERCAPTOPURINE
Application Number
216418
Product Number
1
Dosage Form
-
Strength
20MG/ML
Approval Date
2025-02-26
Regulatory Status
RX
Drug Name
MESNA
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2004-01-09
Active Ingredient
MESNA
Application Number
75739
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2004-01-09
Regulatory Status
RX
Drug Name
METHADONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
1982-01-01
Active Ingredient
METHADONE HYDROCHLORIDE
Application Number
17058
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
METHADONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
1998-04-30
Active Ingredient
METHADONE HYDROCHLORIDE
Application Number
40180
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
1998-04-30
Regulatory Status
RX
Drug Name
METHADONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
5MG/5ML
Approval Date
1982-01-01
Active Ingredient
METHADONE HYDROCHLORIDE
Application Number
87393
Product Number
1
Dosage Form
-
Strength
5MG/5ML
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
METHADONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG/5ML
Approval Date
1982-08-30
Active Ingredient
METHADONE HYDROCHLORIDE
Application Number
87997
Product Number
1
Dosage Form
-
Strength
10MG/5ML
Approval Date
1982-08-30
Regulatory Status
RX
Drug Name
METHADONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1983-03-08
Active Ingredient
METHADONE HYDROCHLORIDE
Application Number
88109
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1983-03-08
Regulatory Status
RX
Drug Name
METHADONE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
1983-03-08
Active Ingredient
METHADONE HYDROCHLORIDE
Application Number
88109
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
1983-03-08
Regulatory Status
RX
Drug Name
METHADONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2025-05-05
Active Ingredient
METHADONE HYDROCHLORIDE
Application Number
218609
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2025-05-05
Regulatory Status
RX
Drug Name
METHADONE HYDROCHLORIDE INTENSOL
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
1988-09-06
Active Ingredient
METHADONE HYDROCHLORIDE
Application Number
89897
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
1988-09-06
Regulatory Status
RX
Drug Name
METHAMPHETAMINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2015-11-17
Active Ingredient
METHAMPHETAMINE HYDROCHLORIDE
Application Number
203846
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2015-11-17
Regulatory Status
RX
Drug Name
METHOTREXATE SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE
Approval Date
1994-08-01
Active Ingredient
METHOTREXATE SODIUM
Application Number
40054
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE
Approval Date
1994-08-01
Regulatory Status
RX
Drug Name
METHOTREXATE SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE/4ML (EQ 25MG BASE/ML)
Approval Date
1986-09-16
Active Ingredient
METHOTREXATE SODIUM
Application Number
89341
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE/4ML (EQ 25MG BASE/ML)
Approval Date
1986-09-16
Regulatory Status
RX
Drug Name
METHOTREXATE SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 200MG BASE/8ML (EQ 25MG BASE/ML)
Approval Date
1986-09-16
Active Ingredient
METHOTREXATE SODIUM
Application Number
89342
Product Number
1
Dosage Form
-
Strength
EQ 200MG BASE/8ML (EQ 25MG BASE/ML)
Approval Date
1986-09-16
Regulatory Status
RX
Drug Name
METHOTREXATE SODIUM PRESERVATIVE FREE
Product Number
1
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
2005-08-12
Active Ingredient
METHOTREXATE SODIUM
Application Number
40632
Product Number
1
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
2005-08-12
Regulatory Status
RX
Drug Name
METHOTREXATE SODIUM PRESERVATIVE FREE
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/2ML (EQ 25MG BASE/ML)
Approval Date
1986-09-16
Active Ingredient
METHOTREXATE SODIUM
Application Number
89340
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/2ML (EQ 25MG BASE/ML)
Approval Date
1986-09-16
Regulatory Status
RX
Drug Name
METHOTREXATE SODIUM PRESERVATIVE FREE
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE/10ML (EQ 25MG BASE/ML)
Approval Date
1986-09-16
Active Ingredient
METHOTREXATE SODIUM
Application Number
89343
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE/10ML (EQ 25MG BASE/ML)
Approval Date
1986-09-16
Regulatory Status
RX
Drug Name
METHYLENE BLUE
Product Number
1
Dosage Form
-
Strength
50MG/10ML (5MG/ML)
Approval Date
2024-12-17
Active Ingredient
METHYLENE BLUE
Application Number
216959
Product Number
1
Dosage Form
-
Strength
50MG/10ML (5MG/ML)
Approval Date
2024-12-17
Regulatory Status
RX
Drug Name
METHYLPREDNISOLONE ACETATE
Product Number
1
Dosage Form
-
Strength
80MG/ML
Approval Date
2025-04-16
Active Ingredient
METHYLPREDNISOLONE ACETATE
Application Number
219145
Product Number
1
Dosage Form
-
Strength
80MG/ML
Approval Date
2025-04-16
Regulatory Status
RX
Drug Name
METHYLPREDNISOLONE SODIUM SUCCINATE
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2016-02-16
Active Ingredient
METHYLPREDNISOLONE SODIUM SUCCINATE
Application Number
202691
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2016-02-16
Regulatory Status
RX
Drug Name
METHYLPREDNISOLONE SODIUM SUCCINATE
Product Number
2
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
2016-02-16
Active Ingredient
METHYLPREDNISOLONE SODIUM SUCCINATE
Application Number
202691
Product Number
2
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
2016-02-16
Regulatory Status
RX
Drug Name
METHYLPREDNISOLONE SODIUM SUCCINATE
Product Number
1
Dosage Form
-
Strength
EQ 40MG BASE/VIAL
Approval Date
2022-09-26
Active Ingredient
METHYLPREDNISOLONE SODIUM SUCCINATE
Application Number
203125
Product Number
1
Dosage Form
-
Strength
EQ 40MG BASE/VIAL
Approval Date
2022-09-26
Regulatory Status
RX
Drug Name
METHYLPREDNISOLONE SODIUM SUCCINATE
Product Number
2
Dosage Form
-
Strength
EQ 125MG BASE/VIAL
Approval Date
2022-09-26
Active Ingredient
METHYLPREDNISOLONE SODIUM SUCCINATE
Application Number
203125
Product Number
2
Dosage Form
-
Strength
EQ 125MG BASE/VIAL
Approval Date
2022-09-26
Regulatory Status
RX
Drug Name
METOPROLOL TARTRATE
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2003-07-07
Active Ingredient
METOPROLOL TARTRATE
Application Number
76495
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2003-07-07
Regulatory Status
RX
Drug Name
METOPROLOL TARTRATE
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2007-05-30
Active Ingredient
METOPROLOL TARTRATE
Application Number
77761
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2007-05-30
Regulatory Status
RX
Drug Name
MICAFUNGIN SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/VIAL
Approval Date
2021-07-09
Active Ingredient
MICAFUNGIN SODIUM
Application Number
213261
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/VIAL
Approval Date
2021-07-09
Regulatory Status
RX
Drug Name
MICAFUNGIN SODIUM
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE/VIAL
Approval Date
2021-07-09
Active Ingredient
MICAFUNGIN SODIUM
Application Number
213261
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE/VIAL
Approval Date
2021-07-09
Regulatory Status
RX
Drug Name
MIDAZOLAM HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/ML
Approval Date
2000-06-20
Active Ingredient
MIDAZOLAM HYDROCHLORIDE
Application Number
75243
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/ML
Approval Date
2000-06-20
Regulatory Status
RX
Drug Name
MIDAZOLAM HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE/ML
Approval Date
2000-06-20
Active Ingredient
MIDAZOLAM HYDROCHLORIDE
Application Number
75243
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE/ML
Approval Date
2000-06-20
Regulatory Status
RX
Drug Name
MIDAZOLAM HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/ML
Approval Date
2000-06-23
Active Ingredient
MIDAZOLAM HYDROCHLORIDE
Application Number
75247
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/ML
Approval Date
2000-06-23
Regulatory Status
RX
Drug Name
MIDAZOLAM HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 1MG BASE/ML
Approval Date
2000-06-23
Active Ingredient
MIDAZOLAM HYDROCHLORIDE
Application Number
75247
Product Number
2
Dosage Form
-
Strength
EQ 1MG BASE/ML
Approval Date
2000-06-23
Regulatory Status
RX
Drug Name
MIDAZOLAM HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/ML
Approval Date
2000-06-20
Active Ingredient
MIDAZOLAM HYDROCHLORIDE
Application Number
75324
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/ML
Approval Date
2000-06-20
Regulatory Status
RX
Drug Name
MIDAZOLAM HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE/ML
Approval Date
2000-06-20
Active Ingredient
MIDAZOLAM HYDROCHLORIDE
Application Number
75324
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE/ML
Approval Date
2000-06-20
Regulatory Status
RX
Drug Name
MIDAZOLAM HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/ML
Approval Date
2000-06-20
Active Ingredient
MIDAZOLAM HYDROCHLORIDE
Application Number
75421
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/ML
Approval Date
2000-06-20
Regulatory Status
RX
Drug Name
MIDAZOLAM HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 1MG BASE/ML
Approval Date
2000-06-20
Active Ingredient
MIDAZOLAM HYDROCHLORIDE
Application Number
75421
Product Number
2
Dosage Form
-
Strength
EQ 1MG BASE/ML
Approval Date
2000-06-20
Regulatory Status
RX
Drug Name
MIDAZOLAM HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE/ML
Approval Date
2002-04-30
Active Ingredient
MIDAZOLAM HYDROCHLORIDE
Application Number
75873
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE/ML
Approval Date
2002-04-30
Regulatory Status
RX
Drug Name
MIDAZOLAM HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/ML
Approval Date
2020-12-11
Active Ingredient
MIDAZOLAM HYDROCHLORIDE
Application Number
212847
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/ML
Approval Date
2020-12-11
Regulatory Status
RX
Drug Name
MIDAZOLAM HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE/ML
Approval Date
2020-12-11
Active Ingredient
MIDAZOLAM HYDROCHLORIDE
Application Number
212847
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE/ML
Approval Date
2020-12-11
Regulatory Status
RX
Drug Name
MIDAZOLAM IN 0.9% SODIUM CHLORIDE
Product Number
1
Dosage Form
-
Strength
50MG/50ML (1MG/ML)
Approval Date
2023-04-17
Active Ingredient
MIDAZOLAM
Application Number
216159
Product Number
1
Dosage Form
-
Strength
50MG/50ML (1MG/ML)
Approval Date
2023-04-17
Regulatory Status
RX
Drug Name
MIDAZOLAM IN 0.9% SODIUM CHLORIDE
Product Number
2
Dosage Form
-
Strength
100MG/100ML (1MG/ML)
Approval Date
2023-04-17
Active Ingredient
MIDAZOLAM
Application Number
216159
Product Number
2
Dosage Form
-
Strength
100MG/100ML (1MG/ML)
Approval Date
2023-04-17
Regulatory Status
RX
Drug Name
MILRINONE LACTATE
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/ML
Approval Date
2002-05-28
Active Ingredient
MILRINONE LACTATE
Application Number
75660
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/ML
Approval Date
2002-05-28
Regulatory Status
RX
Drug Name
MILRINONE LACTATE
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/ML
Approval Date
2010-12-03
Active Ingredient
MILRINONE LACTATE
Application Number
77966
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/ML
Approval Date
2010-12-03
Regulatory Status
RX
Drug Name
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)
Approval Date
2008-05-21
Active Ingredient
MILRINONE LACTATE
Application Number
78113
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)
Approval Date
2008-05-21
Regulatory Status
RX
Drug Name
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)
Approval Date
2008-05-21
Active Ingredient
MILRINONE LACTATE
Application Number
78113
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)
Approval Date
2008-05-21
Regulatory Status
RX
Drug Name
MILRINONE LACTATE IN PLASTIC CONTAINER
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)
Approval Date
2010-01-21
Active Ingredient
MILRINONE LACTATE
Application Number
90038
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)
Approval Date
2010-01-21
Regulatory Status
RX
Drug Name
MILRINONE LACTATE IN PLASTIC CONTAINER
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)
Approval Date
2010-01-21
Active Ingredient
MILRINONE LACTATE
Application Number
90038
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)
Approval Date
2010-01-21
Regulatory Status
RX
Drug Name
MITIGARE
Product Number
1
Dosage Form
-
Strength
0.6MG
Approval Date
2014-09-26
Active Ingredient
COLCHICINE
Application Number
204820
Product Number
1
Dosage Form
-
Strength
0.6MG
Approval Date
2014-09-26
Regulatory Status
RX
Drug Name
MITOMYCIN
Product Number
2
Dosage Form
-
Strength
20MG/VIAL
Approval Date
1995-04-19
Active Ingredient
MITOMYCIN
Application Number
64117
Product Number
2
Dosage Form
-
Strength
20MG/VIAL
Approval Date
1995-04-19
Regulatory Status
RX
Drug Name
MITOMYCIN
Product Number
3
Dosage Form
-
Strength
40MG/VIAL
Approval Date
1999-06-02
Active Ingredient
MITOMYCIN
Application Number
64117
Product Number
3
Dosage Form
-
Strength
40MG/VIAL
Approval Date
1999-06-02
Regulatory Status
RX
Drug Name
MITOMYCIN
Product Number
1
Dosage Form
-
Strength
5MG/VIAL
Approval Date
1999-12-23
Active Ingredient
MITOMYCIN
Application Number
64180
Product Number
1
Dosage Form
-
Strength
5MG/VIAL
Approval Date
1999-12-23
Regulatory Status
RX
Drug Name
MITOMYCIN
Product Number
2
Dosage Form
-
Strength
20MG/VIAL
Approval Date
1999-12-23
Active Ingredient
MITOMYCIN
Application Number
64180
Product Number
2
Dosage Form
-
Strength
20MG/VIAL
Approval Date
1999-12-23
Regulatory Status
RX
Drug Name
MITOXANTRONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE/10ML (EQ 2MG BASE/ML)
Approval Date
2006-04-11
Active Ingredient
MITOXANTRONE HYDROCHLORIDE
Application Number
76611
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE/10ML (EQ 2MG BASE/ML)
Approval Date
2006-04-11
Regulatory Status
RX
Drug Name
MITOXANTRONE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)
Approval Date
2006-04-11
Active Ingredient
MITOXANTRONE HYDROCHLORIDE
Application Number
76611
Product Number
2
Dosage Form
-
Strength
EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)
Approval Date
2006-04-11
Regulatory Status
RX
Drug Name
MITOXANTRONE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 30MG BASE/15ML (EQ 2MG BASE/ML)
Approval Date
2006-04-11
Active Ingredient
MITOXANTRONE HYDROCHLORIDE
Application Number
76611
Product Number
3
Dosage Form
-
Strength
EQ 30MG BASE/15ML (EQ 2MG BASE/ML)
Approval Date
2006-04-11
Regulatory Status
RX
Drug Name
MORPHINE SULFATE
Product Number
1
Dosage Form
-
Strength
10MG/5ML
Approval Date
2008-03-17
Active Ingredient
MORPHINE SULFATE
Application Number
22195
Product Number
1
Dosage Form
-
Strength
10MG/5ML
Approval Date
2008-03-17
Regulatory Status
RX
Drug Name
MORPHINE SULFATE
Product Number
2
Dosage Form
-
Strength
20MG/5ML
Approval Date
2008-03-17
Active Ingredient
MORPHINE SULFATE
Application Number
22195
Product Number
2
Dosage Form
-
Strength
20MG/5ML
Approval Date
2008-03-17
Regulatory Status
RX
Drug Name
MORPHINE SULFATE
Product Number
3
Dosage Form
-
Strength
100MG/5ML
Approval Date
2010-01-25
Active Ingredient
MORPHINE SULFATE
Application Number
22195
Product Number
3
Dosage Form
-
Strength
100MG/5ML
Approval Date
2010-01-25
Regulatory Status
RX
Drug Name
MORPHINE SULFATE
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
2008-03-17
Active Ingredient
MORPHINE SULFATE
Application Number
22207
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
2008-03-17
Regulatory Status
RX
Drug Name
MORPHINE SULFATE
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
2008-03-17
Active Ingredient
MORPHINE SULFATE
Application Number
22207
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
2008-03-17
Regulatory Status
RX
Drug Name
MORPHINE SULFATE
Product Number
1
Dosage Form
-
Strength
4MG/ML
Approval Date
2015-05-21
Active Ingredient
MORPHINE SULFATE
Application Number
205758
Product Number
1
Dosage Form
-
Strength
4MG/ML
Approval Date
2015-05-21
Regulatory Status
RX
Drug Name
MORPHINE SULFATE
Product Number
2
Dosage Form
-
Strength
8MG/ML
Approval Date
2015-05-21
Active Ingredient
MORPHINE SULFATE
Application Number
205758
Product Number
2
Dosage Form
-
Strength
8MG/ML
Approval Date
2015-05-21
Regulatory Status
RX
Drug Name
MORPHINE SULFATE
Product Number
3
Dosage Form
-
Strength
10MG/ML
Approval Date
2015-05-21
Active Ingredient
MORPHINE SULFATE
Application Number
205758
Product Number
3
Dosage Form
-
Strength
10MG/ML
Approval Date
2015-05-21
Regulatory Status
RX
Drug Name
MORPHINE SULFATE
Product Number
1
Dosage Form
-
Strength
2MG/ML
Approval Date
2023-01-12
Active Ingredient
MORPHINE SULFATE
Application Number
211452
Product Number
1
Dosage Form
-
Strength
2MG/ML
Approval Date
2023-01-12
Regulatory Status
RX
Drug Name
MORPHINE SULFATE
Product Number
2
Dosage Form
-
Strength
4MG/ML
Approval Date
2023-01-12
Active Ingredient
MORPHINE SULFATE
Application Number
211452
Product Number
2
Dosage Form
-
Strength
4MG/ML
Approval Date
2023-01-12
Regulatory Status
RX
Drug Name
MORPHINE SULFATE
Product Number
3
Dosage Form
-
Strength
8MG/ML
Approval Date
2023-01-12
Active Ingredient
MORPHINE SULFATE
Application Number
211452
Product Number
3
Dosage Form
-
Strength
8MG/ML
Approval Date
2023-01-12
Regulatory Status
RX
Drug Name
MORPHINE SULFATE
Product Number
4
Dosage Form
-
Strength
10MG/ML
Approval Date
2023-01-12
Active Ingredient
MORPHINE SULFATE
Application Number
211452
Product Number
4
Dosage Form
-
Strength
10MG/ML
Approval Date
2023-01-12
Regulatory Status
RX
Drug Name
MORPHINE SULFATE
Product Number
5
Dosage Form
-
Strength
15MG/ML
Approval Date
2023-01-12
Active Ingredient
MORPHINE SULFATE
Application Number
211452
Product Number
5
Dosage Form
-
Strength
15MG/ML
Approval Date
2023-01-12
Regulatory Status
RX
Drug Name
NALOXONE
Product Number
1
Dosage Form
-
Strength
0.4MG/ML
Approval Date
1986-09-24
Active Ingredient
NALOXONE HYDROCHLORIDE
Application Number
70299
Product Number
1
Dosage Form
-
Strength
0.4MG/ML
Approval Date
1986-09-24
Regulatory Status
RX
Drug Name
NALOXONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2022-06-10
Active Ingredient
NALOXONE HYDROCHLORIDE
Application Number
212300
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2022-06-10
Regulatory Status
RX
Drug Name
NALOXONE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
0.4MG/ML
Approval Date
2024-03-07
Active Ingredient
NALOXONE HYDROCHLORIDE
Application Number
212300
Product Number
2
Dosage Form
-
Strength
0.4MG/ML
Approval Date
2024-03-07
Regulatory Status
RX
Drug Name
NAPROXEN
Product Number
1
Dosage Form
-
Strength
25MG/ML
Approval Date
1994-03-30
Active Ingredient
NAPROXEN
Application Number
74190
Product Number
1
Dosage Form
-
Strength
25MG/ML
Approval Date
1994-03-30
Regulatory Status
RX
Drug Name
NARATRIPTAN
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2010-07-07
Active Ingredient
NARATRIPTAN HYDROCHLORIDE
Application Number
90381
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2010-07-07
Regulatory Status
RX
Drug Name
NARATRIPTAN
Product Number
2
Dosage Form
-
Strength
EQ 2.5MG BASE
Approval Date
2010-07-07
Active Ingredient
NARATRIPTAN HYDROCHLORIDE
Application Number
90381
Product Number
2
Dosage Form
-
Strength
EQ 2.5MG BASE
Approval Date
2010-07-07
Regulatory Status
RX
Drug Name
NEOSTIGMINE METHYLSULFATE
Product Number
1
Dosage Form
-
Strength
5MG/10ML (0.5MG/ML)
Approval Date
2015-12-28
Active Ingredient
NEOSTIGMINE METHYLSULFATE
Application Number
207042
Product Number
1
Dosage Form
-
Strength
5MG/10ML (0.5MG/ML)
Approval Date
2015-12-28
Regulatory Status
RX
Drug Name
NEOSTIGMINE METHYLSULFATE
Product Number
2
Dosage Form
-
Strength
10MG/10ML (1MG/ML)
Approval Date
2015-12-28
Active Ingredient
NEOSTIGMINE METHYLSULFATE
Application Number
207042
Product Number
2
Dosage Form
-
Strength
10MG/10ML (1MG/ML)
Approval Date
2015-12-28
Regulatory Status
RX
Drug Name
NICARDIPINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
25MG/10ML (2.5MG/ML)
Approval Date
2008-07-24
Active Ingredient
NICARDIPINE HYDROCHLORIDE
Application Number
22276
Product Number
1
Dosage Form
-
Strength
25MG/10ML (2.5MG/ML)
Approval Date
2008-07-24
Regulatory Status
RX
Drug Name
NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
Product Number
2
Dosage Form
-
Strength
20MG/200ML (0.1MG/ML)
Approval Date
2016-04-07
Active Ingredient
NICARDIPINE HYDROCHLORIDE
Application Number
22276
Product Number
2
Dosage Form
-
Strength
20MG/200ML (0.1MG/ML)
Approval Date
2016-04-07
Regulatory Status
RX
Drug Name
NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
Product Number
3
Dosage Form
-
Strength
40MG/200ML (0.2MG/ML)
Approval Date
2016-04-07
Active Ingredient
NICARDIPINE HYDROCHLORIDE
Application Number
22276
Product Number
3
Dosage Form
-
Strength
40MG/200ML (0.2MG/ML)
Approval Date
2016-04-07
Regulatory Status
RX
Drug Name
NOREPINEPHRINE BITARTRATE
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/ML
Approval Date
2003-10-31
Active Ingredient
NOREPINEPHRINE BITARTRATE
Application Number
40462
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/ML
Approval Date
2003-10-31
Regulatory Status
RX
Drug Name
NOREPINEPHRINE BITARTRATE
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/ML
Approval Date
2018-11-07
Active Ingredient
NOREPINEPHRINE BITARTRATE
Application Number
203662
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/ML
Approval Date
2018-11-07
Regulatory Status
RX
Drug Name
ONDANSETRON HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE/5ML
Approval Date
2006-12-26
Active Ingredient
ONDANSETRON HYDROCHLORIDE
Application Number
76960
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE/5ML
Approval Date
2006-12-26
Regulatory Status
RX
Drug Name
ONDANSETRON HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE/ML
Approval Date
2006-12-26
Active Ingredient
ONDANSETRON HYDROCHLORIDE
Application Number
76967
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE/ML
Approval Date
2006-12-26
Regulatory Status
RX
Drug Name
ONDANSETRON HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE/ML
Approval Date
2006-12-26
Active Ingredient
ONDANSETRON HYDROCHLORIDE
Application Number
77365
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE/ML
Approval Date
2006-12-26
Regulatory Status
RX
Drug Name
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE/ML
Approval Date
2006-12-26
Active Ingredient
ONDANSETRON HYDROCHLORIDE
Application Number
77011
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE/ML
Approval Date
2006-12-26
Regulatory Status
RX
Drug Name
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE/ML
Approval Date
2006-12-26
Active Ingredient
ONDANSETRON HYDROCHLORIDE
Application Number
77541
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE/ML
Approval Date
2006-12-26
Regulatory Status
RX
Drug Name
ORPHENADRINE CITRATE
Product Number
1
Dosage Form
-
Strength
30MG/ML
Approval Date
2003-03-04
Active Ingredient
ORPHENADRINE CITRATE
Application Number
40463
Product Number
1
Dosage Form
-
Strength
30MG/ML
Approval Date
2003-03-04
Regulatory Status
RX
Drug Name
OXYCODONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
5MG/5ML
Approval Date
2013-07-15
Active Ingredient
OXYCODONE HYDROCHLORIDE
Application Number
204037
Product Number
1
Dosage Form
-
Strength
5MG/5ML
Approval Date
2013-07-15
Regulatory Status
RX
Drug Name
OXYMORPHONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2010-09-27
Active Ingredient
OXYMORPHONE HYDROCHLORIDE
Application Number
90964
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2010-09-27
Regulatory Status
RX
Drug Name
OXYMORPHONE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2010-09-27
Active Ingredient
OXYMORPHONE HYDROCHLORIDE
Application Number
90964
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2010-09-27
Regulatory Status
RX
Drug Name
OXYTOCIN
Product Number
1
Dosage Form
-
Strength
10USP UNITS/ML (10USP UNITS/ML)
Approval Date
1982-01-01
Active Ingredient
OXYTOCIN
Application Number
18243
Product Number
1
Dosage Form
-
Strength
10USP UNITS/ML (10USP UNITS/ML)
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
OXYTOCIN
Product Number
2
Dosage Form
-
Strength
100USP UNITS/10ML (10USP UNITS/ML)
Approval Date
2007-01-10
Active Ingredient
OXYTOCIN
Application Number
18243
Product Number
2
Dosage Form
-
Strength
100USP UNITS/10ML (10USP UNITS/ML)
Approval Date
2007-01-10
Regulatory Status
RX
Drug Name
OXYTOCIN
Product Number
1
Dosage Form
-
Strength
10USP UNITS/ML (10USP UNITS/ML)
Approval Date
2013-02-13
Active Ingredient
OXYTOCIN
Application Number
200219
Product Number
1
Dosage Form
-
Strength
10USP UNITS/ML (10USP UNITS/ML)
Approval Date
2013-02-13
Regulatory Status
RX
Drug Name
PACLITAXEL
Product Number
1
Dosage Form
-
Strength
6MG/ML
Approval Date
2002-01-28
Active Ingredient
PACLITAXEL
Application Number
75190
Product Number
1
Dosage Form
-
Strength
6MG/ML
Approval Date
2002-01-28
Regulatory Status
RX
Drug Name
PAMIDRONATE DISODIUM
Product Number
1
Dosage Form
-
Strength
30MG/10ML (3MG/ML)
Approval Date
2002-03-04
Active Ingredient
PAMIDRONATE DISODIUM
Application Number
21113
Product Number
1
Dosage Form
-
Strength
30MG/10ML (3MG/ML)
Approval Date
2002-03-04
Regulatory Status
RX
Drug Name
PAMIDRONATE DISODIUM
Product Number
2
Dosage Form
-
Strength
90MG/10ML (9MG/ML)
Approval Date
2002-03-04
Active Ingredient
PAMIDRONATE DISODIUM
Application Number
21113
Product Number
2
Dosage Form
-
Strength
90MG/10ML (9MG/ML)
Approval Date
2002-03-04
Regulatory Status
RX
Drug Name
PAMIDRONATE DISODIUM
Product Number
1
Dosage Form
-
Strength
30MG/VIAL
Approval Date
2001-04-30
Active Ingredient
PAMIDRONATE DISODIUM
Application Number
75290
Product Number
1
Dosage Form
-
Strength
30MG/VIAL
Approval Date
2001-04-30
Regulatory Status
RX
Drug Name
PAMIDRONATE DISODIUM
Product Number
3
Dosage Form
-
Strength
90MG/VIAL
Approval Date
2001-04-30
Active Ingredient
PAMIDRONATE DISODIUM
Application Number
75290
Product Number
3
Dosage Form
-
Strength
90MG/VIAL
Approval Date
2001-04-30
Regulatory Status
RX
Drug Name
PANTOPRAZOLE SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 40MG BASE/VIAL
Approval Date
2017-06-30
Active Ingredient
PANTOPRAZOLE SODIUM
Application Number
209463
Product Number
1
Dosage Form
-
Strength
EQ 40MG BASE/VIAL
Approval Date
2017-06-30
Regulatory Status
RX
Drug Name
PENICILLIN V POTASSIUM
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
2013-10-11
Active Ingredient
PENICILLIN V POTASSIUM
Application Number
90549
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
2013-10-11
Regulatory Status
RX
Drug Name
PENICILLIN V POTASSIUM
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
2013-10-11
Active Ingredient
PENICILLIN V POTASSIUM
Application Number
90549
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
2013-10-11
Regulatory Status
RX
Drug Name
PENTOBARBITAL SODIUM
Product Number
1
Dosage Form
-
Strength
50MG/ML
Approval Date
2017-11-13
Active Ingredient
PENTOBARBITAL SODIUM
Application Number
203619
Product Number
1
Dosage Form
-
Strength
50MG/ML
Approval Date
2017-11-13
Regulatory Status
RX
Drug Name
PHENTOLAMINE MESYLATE
Product Number
1
Dosage Form
-
Strength
5MG/VIAL
Approval Date
1998-03-11
Active Ingredient
PHENTOLAMINE MESYLATE
Application Number
40235
Product Number
1
Dosage Form
-
Strength
5MG/VIAL
Approval Date
1998-03-11
Regulatory Status
RX
Drug Name
PHENYLEPHRINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG/ML (10MG/ML)
Approval Date
2012-12-20
Active Ingredient
PHENYLEPHRINE HYDROCHLORIDE
Application Number
203826
Product Number
1
Dosage Form
-
Strength
10MG/ML (10MG/ML)
Approval Date
2012-12-20
Regulatory Status
RX
Drug Name
PHENYLEPHRINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
50MG/5ML (10MG/ML)
Approval Date
2019-06-19
Active Ingredient
PHENYLEPHRINE HYDROCHLORIDE
Application Number
203826
Product Number
2
Dosage Form
-
Strength
50MG/5ML (10MG/ML)
Approval Date
2019-06-19
Regulatory Status
RX
Drug Name
PHENYLEPHRINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
100MG/10ML (10MG/ML)
Approval Date
2019-06-19
Active Ingredient
PHENYLEPHRINE HYDROCHLORIDE
Application Number
203826
Product Number
3
Dosage Form
-
Strength
100MG/10ML (10MG/ML)
Approval Date
2019-06-19
Regulatory Status
RX
Drug Name
PHENYTOIN SODIUM
Product Number
1
Dosage Form
-
Strength
50MG/ML
Approval Date
1982-01-01
Active Ingredient
PHENYTOIN SODIUM
Application Number
84307
Product Number
1
Dosage Form
-
Strength
50MG/ML
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
POSACONAZOLE
Product Number
1
Dosage Form
-
Strength
40MG/ML
Approval Date
2020-05-15
Active Ingredient
POSACONAZOLE
Application Number
208773
Product Number
1
Dosage Form
-
Strength
40MG/ML
Approval Date
2020-05-15
Regulatory Status
RX
Drug Name
PREDNISONE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
1982-01-01
Active Ingredient
PREDNISONE
Application Number
80352
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
PREDNISONE
Product Number
2
Dosage Form
-
Strength
1MG
Approval Date
1982-04-22
Active Ingredient
PREDNISONE
Application Number
80352
Product Number
2
Dosage Form
-
Strength
1MG
Approval Date
1982-04-22
Regulatory Status
RX
Drug Name
PREDNISONE
Product Number
3
Dosage Form
-
Strength
2.5MG
Approval Date
1982-04-22
Active Ingredient
PREDNISONE
Application Number
80352
Product Number
3
Dosage Form
-
Strength
2.5MG
Approval Date
1982-04-22
Regulatory Status
RX
Drug Name
PREDNISONE
Product Number
4
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Active Ingredient
PREDNISONE
Application Number
80352
Product Number
4
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
PREDNISONE
Product Number
5
Dosage Form
-
Strength
20MG
Approval Date
1982-01-01
Active Ingredient
PREDNISONE
Application Number
80352
Product Number
5
Dosage Form
-
Strength
20MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
PREDNISONE
Product Number
6
Dosage Form
-
Strength
50MG
Approval Date
1982-01-01
Active Ingredient
PREDNISONE
Application Number
80352
Product Number
6
Dosage Form
-
Strength
50MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
PREDNISONE
Product Number
1
Dosage Form
-
Strength
5MG/5ML
Approval Date
1984-11-08
Active Ingredient
PREDNISONE
Application Number
88703
Product Number
1
Dosage Form
-
Strength
5MG/5ML
Approval Date
1984-11-08
Regulatory Status
RX
Drug Name
PREDNISONE INTENSOL
Product Number
1
Dosage Form
-
Strength
5MG/ML
Approval Date
1985-02-20
Active Ingredient
PREDNISONE
Application Number
88810
Product Number
1
Dosage Form
-
Strength
5MG/ML
Approval Date
1985-02-20
Regulatory Status
RX
Drug Name
PROCHLORPERAZINE EDISYLATE
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/ML
Approval Date
1989-08-29
Active Ingredient
PROCHLORPERAZINE EDISYLATE
Application Number
89903
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/ML
Approval Date
1989-08-29
Regulatory Status
RX
Drug Name
PROGESTERONE
Product Number
1
Dosage Form
-
Strength
50MG/ML
Approval Date
2010-10-28
Active Ingredient
PROGESTERONE
Application Number
91033
Product Number
1
Dosage Form
-
Strength
50MG/ML
Approval Date
2010-10-28
Regulatory Status
RX
Drug Name
PROMETHAZINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
25MG/ML
Approval Date
1982-01-01
Active Ingredient
PROMETHAZINE HYDROCHLORIDE
Application Number
83312
Product Number
1
Dosage Form
-
Strength
25MG/ML
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
PROMETHAZINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
50MG/ML
Approval Date
1982-01-01
Active Ingredient
PROMETHAZINE HYDROCHLORIDE
Application Number
83312
Product Number
2
Dosage Form
-
Strength
50MG/ML
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
PROPOFOL
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2005-04-19
Active Ingredient
PROPOFOL
Application Number
74848
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2005-04-19
Regulatory Status
RX
Drug Name
PROPRANOLOL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
40MG/5ML
Approval Date
1987-05-15
Active Ingredient
PROPRANOLOL HYDROCHLORIDE
Application Number
70690
Product Number
1
Dosage Form
-
Strength
40MG/5ML
Approval Date
1987-05-15
Regulatory Status
RX
Drug Name
PROPRANOLOL HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
20MG/5ML
Approval Date
1987-05-15
Active Ingredient
PROPRANOLOL HYDROCHLORIDE
Application Number
70690
Product Number
2
Dosage Form
-
Strength
20MG/5ML
Approval Date
1987-05-15
Regulatory Status
RX
Drug Name
PROPRANOLOL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2008-01-31
Active Ingredient
PROPRANOLOL HYDROCHLORIDE
Application Number
77760
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2008-01-31
Regulatory Status
RX
Drug Name
PRUCALOPRIDE SUCCINATE
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2025-06-24
Active Ingredient
PRUCALOPRIDE SUCCINATE
Application Number
217662
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2025-06-24
Regulatory Status
RX
Drug Name
PRUCALOPRIDE SUCCINATE
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2025-06-24
Active Ingredient
PRUCALOPRIDE SUCCINATE
Application Number
217662
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2025-06-24
Regulatory Status
RX
Drug Name
PYRAZINAMIDE
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
1992-06-30
Active Ingredient
PYRAZINAMIDE
Application Number
81319
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
1992-06-30
Regulatory Status
RX
Drug Name
QUETIAPINE FUMARATE
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2012-03-27
Active Ingredient
QUETIAPINE FUMARATE
Application Number
90120
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2012-03-27
Regulatory Status
RX
Drug Name
QUETIAPINE FUMARATE
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2012-03-27
Active Ingredient
QUETIAPINE FUMARATE
Application Number
90749
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2012-03-27
Regulatory Status
RX
Drug Name
QUETIAPINE FUMARATE
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2012-03-27
Active Ingredient
QUETIAPINE FUMARATE
Application Number
90749
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2012-03-27
Regulatory Status
RX
Drug Name
QUETIAPINE FUMARATE
Product Number
3
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
2012-03-27
Active Ingredient
QUETIAPINE FUMARATE
Application Number
90749
Product Number
3
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
2012-03-27
Regulatory Status
RX
Drug Name
QUETIAPINE FUMARATE
Product Number
4
Dosage Form
-
Strength
EQ 300MG BASE
Approval Date
2012-03-27
Active Ingredient
QUETIAPINE FUMARATE
Application Number
90749
Product Number
4
Dosage Form
-
Strength
EQ 300MG BASE
Approval Date
2012-03-27
Regulatory Status
RX
Drug Name
QUETIAPINE FUMARATE
Product Number
5
Dosage Form
-
Strength
EQ 400MG BASE
Approval Date
2012-03-27
Active Ingredient
QUETIAPINE FUMARATE
Application Number
90749
Product Number
5
Dosage Form
-
Strength
EQ 400MG BASE
Approval Date
2012-03-27
Regulatory Status
RX
Drug Name
RAMIPRIL
Product Number
1
Dosage Form
-
Strength
1.25MG
Approval Date
2008-06-18
Active Ingredient
RAMIPRIL
Application Number
77900
Product Number
1
Dosage Form
-
Strength
1.25MG
Approval Date
2008-06-18
Regulatory Status
RX
Drug Name
RAMIPRIL
Product Number
2
Dosage Form
-
Strength
2.5MG
Approval Date
2008-06-18
Active Ingredient
RAMIPRIL
Application Number
77900
Product Number
2
Dosage Form
-
Strength
2.5MG
Approval Date
2008-06-18
Regulatory Status
RX
Drug Name
RAMIPRIL
Product Number
3
Dosage Form
-
Strength
5MG
Approval Date
2008-06-18
Active Ingredient
RAMIPRIL
Application Number
77900
Product Number
3
Dosage Form
-
Strength
5MG
Approval Date
2008-06-18
Regulatory Status
RX
Drug Name
RAMIPRIL
Product Number
4
Dosage Form
-
Strength
10MG
Approval Date
2008-06-18
Active Ingredient
RAMIPRIL
Application Number
77900
Product Number
4
Dosage Form
-
Strength
10MG
Approval Date
2008-06-18
Regulatory Status
RX
Drug Name
REGADENOSON
Product Number
1
Dosage Form
-
Strength
0.4MG/5ML (0.08MG/ML)
Approval Date
2023-02-02
Active Ingredient
REGADENOSON
Application Number
215827
Product Number
1
Dosage Form
-
Strength
0.4MG/5ML (0.08MG/ML)
Approval Date
2023-02-02
Regulatory Status
RX
Drug Name
REMIFENTANIL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/VIAL
Approval Date
2020-10-13
Active Ingredient
REMIFENTANIL HYDROCHLORIDE
Application Number
210594
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/VIAL
Approval Date
2020-10-13
Regulatory Status
RX
Drug Name
REMIFENTANIL HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE/VIAL
Approval Date
2020-10-13
Active Ingredient
REMIFENTANIL HYDROCHLORIDE
Application Number
210594
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE/VIAL
Approval Date
2020-10-13
Regulatory Status
RX
Drug Name
REMIFENTANIL HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE/VIAL
Approval Date
2020-10-13
Active Ingredient
REMIFENTANIL HYDROCHLORIDE
Application Number
210594
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE/VIAL
Approval Date
2020-10-13
Regulatory Status
RX
Drug Name
RIFAMPIN
Product Number
1
Dosage Form
-
Strength
600MG/VIAL
Approval Date
1999-10-29
Active Ingredient
RIFAMPIN
Application Number
64217
Product Number
1
Dosage Form
-
Strength
600MG/VIAL
Approval Date
1999-10-29
Regulatory Status
RX
Drug Name
RIFAMPIN
Product Number
1
Dosage Form
-
Strength
600MG/VIAL
Approval Date
2016-03-03
Active Ingredient
RIFAMPIN
Application Number
205039
Product Number
1
Dosage Form
-
Strength
600MG/VIAL
Approval Date
2016-03-03
Regulatory Status
RX
Drug Name
ROBAXIN
Product Number
1
Dosage Form
-
Strength
1GM/10ML (100MG/ML)
Approval Date
1982-01-01
Active Ingredient
METHOCARBAMOL
Application Number
11790
Product Number
1
Dosage Form
-
Strength
1GM/10ML (100MG/ML)
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
ROBINUL
Product Number
1
Dosage Form
-
Strength
0.2MG/ML
Approval Date
1982-01-01
Active Ingredient
GLYCOPYRROLATE
Application Number
17558
Product Number
1
Dosage Form
-
Strength
0.2MG/ML
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
ROPIVACAINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
200MG/100ML (2MG/ML)
Approval Date
2024-08-15
Active Ingredient
ROPIVACAINE HYDROCHLORIDE
Application Number
211907
Product Number
1
Dosage Form
-
Strength
200MG/100ML (2MG/ML)
Approval Date
2024-08-15
Regulatory Status
RX
Drug Name
ROPIVACAINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
400MG/200ML (2MG/ML)
Approval Date
2024-08-15
Active Ingredient
ROPIVACAINE HYDROCHLORIDE
Application Number
211907
Product Number
2
Dosage Form
-
Strength
400MG/200ML (2MG/ML)
Approval Date
2024-08-15
Regulatory Status
RX
Drug Name
ROPIVACAINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
500MG/100ML (5MG/ML)
Approval Date
2024-08-15
Active Ingredient
ROPIVACAINE HYDROCHLORIDE
Application Number
211907
Product Number
3
Dosage Form
-
Strength
500MG/100ML (5MG/ML)
Approval Date
2024-08-15
Regulatory Status
RX
Drug Name
ROPIVACAINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
40MG/20ML (2MG/ML)
Approval Date
2020-07-20
Active Ingredient
ROPIVACAINE HYDROCHLORIDE
Application Number
214074
Product Number
1
Dosage Form
-
Strength
40MG/20ML (2MG/ML)
Approval Date
2020-07-20
Regulatory Status
RX
Drug Name
ROPIVACAINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
150MG/30ML (5MG/ML)
Approval Date
2020-07-20
Active Ingredient
ROPIVACAINE HYDROCHLORIDE
Application Number
214074
Product Number
2
Dosage Form
-
Strength
150MG/30ML (5MG/ML)
Approval Date
2020-07-20
Regulatory Status
RX
Drug Name
ROPIVACAINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
150MG/20ML (7.5MG/ML)
Approval Date
2020-07-20
Active Ingredient
ROPIVACAINE HYDROCHLORIDE
Application Number
214074
Product Number
3
Dosage Form
-
Strength
150MG/20ML (7.5MG/ML)
Approval Date
2020-07-20
Regulatory Status
RX
Drug Name
ROPIVACAINE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
200MG/20ML (10MG/ML)
Approval Date
2020-07-20
Active Ingredient
ROPIVACAINE HYDROCHLORIDE
Application Number
214074
Product Number
4
Dosage Form
-
Strength
200MG/20ML (10MG/ML)
Approval Date
2020-07-20
Regulatory Status
RX
Drug Name
RUFINAMIDE
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2016-05-16
Active Ingredient
RUFINAMIDE
Application Number
204988
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2016-05-16
Regulatory Status
RX
Drug Name
RUFINAMIDE
Product Number
2
Dosage Form
-
Strength
400MG
Approval Date
2016-05-16
Active Ingredient
RUFINAMIDE
Application Number
204988
Product Number
2
Dosage Form
-
Strength
400MG
Approval Date
2016-05-16
Regulatory Status
RX
Drug Name
RUFINAMIDE
Product Number
1
Dosage Form
-
Strength
40MG/ML
Approval Date
2019-04-23
Active Ingredient
RUFINAMIDE
Application Number
207363
Product Number
1
Dosage Form
-
Strength
40MG/ML
Approval Date
2019-04-23
Regulatory Status
RX
Drug Name
SAPROPTERIN DIHYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2025-06-11
Active Ingredient
SAPROPTERIN DIHYDROCHLORIDE
Application Number
218797
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2025-06-11
Regulatory Status
RX
Drug Name
SODIUM ACETATE
Product Number
1
Dosage Form
-
Strength
40MEQ/20ML (2MEQ/ML)
Approval Date
2024-03-15
Active Ingredient
SODIUM ACETATE
Application Number
216920
Product Number
1
Dosage Form
-
Strength
40MEQ/20ML (2MEQ/ML)
Approval Date
2024-03-15
Regulatory Status
RX
Drug Name
SODIUM ACETATE
Product Number
2
Dosage Form
-
Strength
100MEQ/50ML (2MEQ/ML)
Approval Date
2024-03-15
Active Ingredient
SODIUM ACETATE
Application Number
216920
Product Number
2
Dosage Form
-
Strength
100MEQ/50ML (2MEQ/ML)
Approval Date
2024-03-15
Regulatory Status
RX
Drug Name
SODIUM ACETATE
Product Number
3
Dosage Form
-
Strength
200MEQ/100ML (2MEQ/ML)
Approval Date
2024-03-15
Active Ingredient
SODIUM ACETATE
Application Number
216920
Product Number
3
Dosage Form
-
Strength
200MEQ/100ML (2MEQ/ML)
Approval Date
2024-03-15
Regulatory Status
RX
Drug Name
SODIUM CHLORIDE 0.9%
Product Number
1
Dosage Form
-
Strength
18MG/2ML (9MG/ML)
Approval Date
2013-09-24
Active Ingredient
SODIUM CHLORIDE
Application Number
201833
Product Number
1
Dosage Form
-
Strength
18MG/2ML (9MG/ML)
Approval Date
2013-09-24
Regulatory Status
RX
Drug Name
SODIUM CHLORIDE 0.9%
Product Number
2
Dosage Form
-
Strength
90MG/10ML (9MG/ML)
Approval Date
2015-01-07
Active Ingredient
SODIUM CHLORIDE
Application Number
201833
Product Number
2
Dosage Form
-
Strength
90MG/10ML (9MG/ML)
Approval Date
2015-01-07
Regulatory Status
RX
Drug Name
SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE
Product Number
1
Dosage Form
-
Strength
EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)
Approval Date
2011-03-31
Active Ingredient
SODIUM FERRIC GLUCONATE COMPLEX
Application Number
78215
Product Number
1
Dosage Form
-
Strength
EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)
Approval Date
2011-03-31
Regulatory Status
RX
Drug Name
SODIUM TETRADECYL SULFATE
Product Number
1
Dosage Form
-
Strength
60MG/2ML (30MG/ML)
Approval Date
2019-12-09
Active Ingredient
SODIUM TETRADECYL SULFATE
Application Number
209937
Product Number
1
Dosage Form
-
Strength
60MG/2ML (30MG/ML)
Approval Date
2019-12-09
Regulatory Status
RX
Drug Name
SOLRIAMFETOL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2026-06-17
Active Ingredient
SOLRIAMFETOL HYDROCHLORIDE
Application Number
218016
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2026-06-17
Regulatory Status
RX
Drug Name
SOLRIAMFETOL HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2026-06-17
Active Ingredient
SOLRIAMFETOL HYDROCHLORIDE
Application Number
218016
Product Number
2
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2026-06-17
Regulatory Status
RX
Drug Name
STERILE WATER FOR INJECTION
Product Number
1
Dosage Form
-
Strength
100% (10ML)
Approval Date
2015-09-02
Active Ingredient
STERILE WATER FOR INJECTION
Application Number
206369
Product Number
1
Dosage Form
-
Strength
100% (10ML)
Approval Date
2015-09-02
Regulatory Status
RX
Drug Name
STERILE WATER FOR INJECTION
Product Number
1
Dosage Form
-
Strength
100%
Approval Date
2023-01-31
Active Ingredient
STERILE WATER FOR INJECTION
Application Number
212735
Product Number
1
Dosage Form
-
Strength
100%
Approval Date
2023-01-31
Regulatory Status
RX
Drug Name
SUCCINYLCHOLINE CHLORIDE
Product Number
1
Dosage Form
-
Strength
20MG/ML
Approval Date
2020-06-12
Active Ingredient
SUCCINYLCHOLINE CHLORIDE
Application Number
213229
Product Number
1
Dosage Form
-
Strength
20MG/ML
Approval Date
2020-06-12
Regulatory Status
RX
Drug Name
SUGAMMADEX SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 200MG BASE/2ML (EQ 100MG BASE/ML)
Approval Date
2026-07-28
Active Ingredient
SUGAMMADEX SODIUM
Application Number
218727
Product Number
1
Dosage Form
-
Strength
EQ 200MG BASE/2ML (EQ 100MG BASE/ML)
Approval Date
2026-07-28
Regulatory Status
RX
Drug Name
SUGAMMADEX SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 200MG BASE/2ML (EQ 100MG BASE/ML)
Approval Date
2026-07-28
Active Ingredient
SUGAMMADEX SODIUM
Application Number
218728
Product Number
1
Dosage Form
-
Strength
EQ 200MG BASE/2ML (EQ 100MG BASE/ML)
Approval Date
2026-07-28
Regulatory Status
RX
Drug Name
SUGAMMADEX SODIUM
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE/5ML (EQ 100MG BASE/ML)
Approval Date
2026-07-28
Active Ingredient
SUGAMMADEX SODIUM
Application Number
218728
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE/5ML (EQ 100MG BASE/ML)
Approval Date
2026-07-28
Regulatory Status
RX
Drug Name
SUMATRIPTAN SUCCINATE
Product Number
1
Dosage Form
-
Strength
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
Approval Date
2009-02-06
Active Ingredient
SUMATRIPTAN SUCCINATE
Application Number
79123
Product Number
1
Dosage Form
-
Strength
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
Approval Date
2009-02-06
Regulatory Status
RX
Drug Name
SUMATRIPTAN SUCCINATE
Product Number
1
Dosage Form
-
Strength
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
Approval Date
2013-09-16
Active Ingredient
SUMATRIPTAN SUCCINATE
Application Number
200183
Product Number
1
Dosage Form
-
Strength
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
Approval Date
2013-09-16
Regulatory Status
RX
Drug Name
TERBUTALINE SULFATE
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2009-05-20
Active Ingredient
TERBUTALINE SULFATE
Application Number
78630
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2009-05-20
Regulatory Status
RX
Drug Name
TESTOSTERONE CYPIONATE
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2010-07-15
Active Ingredient
TESTOSTERONE CYPIONATE
Application Number
90387
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2010-07-15
Regulatory Status
RX
Drug Name
TESTOSTERONE CYPIONATE
Product Number
2
Dosage Form
-
Strength
200MG/ML
Approval Date
2010-07-15
Active Ingredient
TESTOSTERONE CYPIONATE
Application Number
90387
Product Number
2
Dosage Form
-
Strength
200MG/ML
Approval Date
2010-07-15
Regulatory Status
RX
Drug Name
TESTOSTERONE CYPIONATE
Product Number
1
Dosage Form
-
Strength
200MG/ML
Approval Date
2012-05-01
Active Ingredient
TESTOSTERONE CYPIONATE
Application Number
91244
Product Number
1
Dosage Form
-
Strength
200MG/ML
Approval Date
2012-05-01
Regulatory Status
RX
Drug Name
TESTOSTERONE ENANTHATE
Product Number
1
Dosage Form
-
Strength
200MG/ML
Approval Date
2012-09-18
Active Ingredient
TESTOSTERONE ENANTHATE
Application Number
91120
Product Number
1
Dosage Form
-
Strength
200MG/ML
Approval Date
2012-09-18
Regulatory Status
RX
Drug Name
THIOTEPA
Product Number
1
Dosage Form
-
Strength
100MG/VIAL
Approval Date
2023-09-05
Active Ingredient
THIOTEPA
Application Number
211755
Product Number
1
Dosage Form
-
Strength
100MG/VIAL
Approval Date
2023-09-05
Regulatory Status
RX
Drug Name
TOBRAMYCIN
Product Number
1
Dosage Form
-
Strength
300MG/5ML
Approval Date
2014-05-28
Active Ingredient
TOBRAMYCIN
Application Number
201422
Product Number
1
Dosage Form
-
Strength
300MG/5ML
Approval Date
2014-05-28
Regulatory Status
RX
Drug Name
TOBRAMYCIN SULFATE
Product Number
1
Dosage Form
-
Strength
EQ 40MG BASE/ML
Approval Date
1991-04-26
Active Ingredient
TOBRAMYCIN SULFATE
Application Number
63117
Product Number
1
Dosage Form
-
Strength
EQ 40MG BASE/ML
Approval Date
1991-04-26
Regulatory Status
RX
Drug Name
TOFACITINIB CITRATE
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/ML
Approval Date
2023-09-25
Active Ingredient
TOFACITINIB CITRATE
Application Number
216878
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/ML
Approval Date
2023-09-25
Regulatory Status
RX
Drug Name
TORSEMIDE
Product Number
3
Dosage Form
-
Strength
20MG
Approval Date
2005-03-01
Active Ingredient
TORSEMIDE
Application Number
76943
Product Number
3
Dosage Form
-
Strength
20MG
Approval Date
2005-03-01
Regulatory Status
RX
Drug Name
TRIAMCINOLONE ACETONIDE
Product Number
1
Dosage Form
-
Strength
40MG/ML
Approval Date
2024-12-09
Active Ingredient
TRIAMCINOLONE ACETONIDE
Application Number
215254
Product Number
1
Dosage Form
-
Strength
40MG/ML
Approval Date
2024-12-09
Regulatory Status
RX
Drug Name
TYZAVAN
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/100ML (EQ 5MG BASE/ML)
Approval Date
2019-02-15
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
211962
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/100ML (EQ 5MG BASE/ML)
Approval Date
2019-02-15
Regulatory Status
RX
Drug Name
TYZAVAN
Product Number
2
Dosage Form
-
Strength
EQ 1GM BASE/200ML (EQ 5MG BASE/ML)
Approval Date
2019-02-15
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
211962
Product Number
2
Dosage Form
-
Strength
EQ 1GM BASE/200ML (EQ 5MG BASE/ML)
Approval Date
2019-02-15
Regulatory Status
RX
Drug Name
TYZAVAN
Product Number
3
Dosage Form
-
Strength
EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML)
Approval Date
2019-02-15
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
211962
Product Number
3
Dosage Form
-
Strength
EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML)
Approval Date
2019-02-15
Regulatory Status
RX
Drug Name
TYZAVAN
Product Number
4
Dosage Form
-
Strength
EQ 2GM BASE/400ML (EQ 5MG BASE/ML)
Approval Date
2019-02-15
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
211962
Product Number
4
Dosage Form
-
Strength
EQ 2GM BASE/400ML (EQ 5MG BASE/ML)
Approval Date
2019-02-15
Regulatory Status
RX
Drug Name
TYZAVAN
Product Number
5
Dosage Form
-
Strength
EQ 750MG BASE/150ML (EQ 5MG BASE/ML)
Approval Date
2020-05-13
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
211962
Product Number
5
Dosage Form
-
Strength
EQ 750MG BASE/150ML (EQ 5MG BASE/ML)
Approval Date
2020-05-13
Regulatory Status
RX
Drug Name
TYZAVAN
Product Number
6
Dosage Form
-
Strength
EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML)
Approval Date
2020-05-13
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
211962
Product Number
6
Dosage Form
-
Strength
EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML)
Approval Date
2020-05-13
Regulatory Status
RX
Drug Name
TYZAVAN
Product Number
7
Dosage Form
-
Strength
EQ 1.75GM BASE/350ML (EQ 5MG BASE/ML)
Approval Date
2020-05-13
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
211962
Product Number
7
Dosage Form
-
Strength
EQ 1.75GM BASE/350ML (EQ 5MG BASE/ML)
Approval Date
2020-05-13
Regulatory Status
RX
Drug Name
VALPROATE SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE/ML
Approval Date
2010-02-17
Active Ingredient
VALPROATE SODIUM
Application Number
78523
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE/ML
Approval Date
2010-02-17
Regulatory Status
RX
Drug Name
VALRUBICIN
Product Number
1
Dosage Form
-
Strength
40MG/ML
Approval Date
2019-04-19
Active Ingredient
VALRUBICIN
Application Number
206430
Product Number
1
Dosage Form
-
Strength
40MG/ML
Approval Date
2019-04-19
Regulatory Status
RX
Drug Name
VANCOMYCIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
2020-08-11
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
203300
Product Number
2
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
2020-08-11
Regulatory Status
RX
Drug Name
VANCOMYCIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2015-12-28
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
204107
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2015-12-28
Regulatory Status
RX
Drug Name
VANCOMYCIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
2015-12-28
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
204107
Product Number
2
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
2015-12-28
Regulatory Status
RX
Drug Name
VANCOMYCIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 5GM BASE/VIAL
Approval Date
2018-10-15
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
204360
Product Number
1
Dosage Form
-
Strength
EQ 5GM BASE/VIAL
Approval Date
2018-10-15
Regulatory Status
RX
Drug Name
VANCOMYCIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 10GM BASE/VIAL
Approval Date
2018-10-15
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
204360
Product Number
2
Dosage Form
-
Strength
EQ 10GM BASE/VIAL
Approval Date
2018-10-15
Regulatory Status
RX
Drug Name
VANCOMYCIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 750MG BASE/VIAL
Approval Date
2018-10-03
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
206616
Product Number
1
Dosage Form
-
Strength
EQ 750MG BASE/VIAL
Approval Date
2018-10-03
Regulatory Status
RX
Drug Name
VANCOMYCIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 1.25GM BASE/VIAL
Approval Date
2023-06-29
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
217489
Product Number
1
Dosage Form
-
Strength
EQ 1.25GM BASE/VIAL
Approval Date
2023-06-29
Regulatory Status
RX
Drug Name
VANCOMYCIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 1.5GM BASE/VIAL
Approval Date
2023-06-29
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
217489
Product Number
2
Dosage Form
-
Strength
EQ 1.5GM BASE/VIAL
Approval Date
2023-06-29
Regulatory Status
RX
Drug Name
VECURONIUM BROMIDE
Product Number
1
Dosage Form
-
Strength
10MG/VIAL
Approval Date
2000-06-13
Active Ingredient
VECURONIUM BROMIDE
Application Number
75549
Product Number
1
Dosage Form
-
Strength
10MG/VIAL
Approval Date
2000-06-13
Regulatory Status
RX
Drug Name
VECURONIUM BROMIDE
Product Number
2
Dosage Form
-
Strength
20MG/VIAL
Approval Date
2000-06-13
Active Ingredient
VECURONIUM BROMIDE
Application Number
75549
Product Number
2
Dosage Form
-
Strength
20MG/VIAL
Approval Date
2000-06-13
Regulatory Status
RX
Drug Name
VECURONIUM BROMIDE
Product Number
1
Dosage Form
-
Strength
10MG/VIAL
Approval Date
2019-07-30
Active Ingredient
VECURONIUM BROMIDE
Application Number
203725
Product Number
1
Dosage Form
-
Strength
10MG/VIAL
Approval Date
2019-07-30
Regulatory Status
RX
Drug Name
VECURONIUM BROMIDE
Product Number
2
Dosage Form
-
Strength
20MG/VIAL
Approval Date
2019-07-30
Active Ingredient
VECURONIUM BROMIDE
Application Number
203725
Product Number
2
Dosage Form
-
Strength
20MG/VIAL
Approval Date
2019-07-30
Regulatory Status
RX
Drug Name
VIGABATRIN
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2022-08-29
Active Ingredient
VIGABATRIN
Application Number
213104
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2022-08-29
Regulatory Status
RX
Drug Name
VINBLASTINE SULFATE
Product Number
1
Dosage Form
-
Strength
10MG/VIAL
Approval Date
1987-04-09
Active Ingredient
VINBLASTINE SULFATE
Application Number
89395
Product Number
1
Dosage Form
-
Strength
10MG/VIAL
Approval Date
1987-04-09
Regulatory Status
RX
Drug Name
VINORELBINE TARTRATE
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/ML
Approval Date
2003-06-10
Active Ingredient
VINORELBINE TARTRATE
Application Number
75992
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/ML
Approval Date
2003-06-10
Regulatory Status
RX
Drug Name
VINORELBINE TARTRATE
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/ML
Approval Date
2003-12-11
Active Ingredient
VINORELBINE TARTRATE
Application Number
76461
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/ML
Approval Date
2003-12-11
Regulatory Status
RX
Drug Name
VORICONAZOLE
Product Number
1
Dosage Form
-
Strength
200MG/VIAL
Approval Date
2017-03-09
Active Ingredient
VORICONAZOLE
Application Number
208562
Product Number
1
Dosage Form
-
Strength
200MG/VIAL
Approval Date
2017-03-09
Regulatory Status
RX
Drug Name
ZALEPLON
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2008-06-06
Active Ingredient
ZALEPLON
Application Number
77237
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2008-06-06
Regulatory Status
RX
Drug Name
ZALEPLON
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2008-06-06
Active Ingredient
ZALEPLON
Application Number
77237
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2008-06-06
Regulatory Status
RX
Drug Name
ZOLEDRONIC ACID
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE/5ML
Approval Date
2013-06-03
Active Ingredient
ZOLEDRONIC ACID
Application Number
202182
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE/5ML
Approval Date
2013-06-03
Regulatory Status
RX
Drug Status Breakdown
585 total- RX
Official Source
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Drug Name
ABIRATERONE ACETATE
Application Number
208339
Product Number
1
Active Ingredient
ABIRATERONE ACETATE
Dosage Form
-
Strength
250MG
FDA Approved Drug Data
Approved drug product information
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