Viatris RX
FDA Approved Drugs
Viatris 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 511
- Latest Approval Date Jul 28, 2026
- Data Source FDA
- First Approval Date Jan 01, 1982
Company Overview
Social Profiles
Company Snapshot
Viatris RX
Robert J. Coury Global Center 1000 Mylan Blvd. Canonsburg, PA 15317
U.S.A
www.viatris.com/en HRServiceCenter@Viatris.com View on MapFDA Approved Drug Records ( 511 records )
Drug Name
ABACAVIR SULFATE
Product Number
1
Dosage Form
-
Strength
EQ 300MG BASE
Approval Date
2012-06-18
Active Ingredient
ABACAVIR SULFATE
Application Number
91294
Product Number
1
Dosage Form
-
Strength
EQ 300MG BASE
Approval Date
2012-06-18
Regulatory Status
RX
Drug Name
ABIRATERONE ACETATE
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2018-10-31
Active Ingredient
ABIRATERONE ACETATE
Application Number
208446
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2018-10-31
Regulatory Status
RX
Drug Name
ABIRATERONE ACETATE
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2020-12-14
Active Ingredient
ABIRATERONE ACETATE
Application Number
208446
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2020-12-14
Regulatory Status
RX
Drug Name
ACAMPROSATE CALCIUM
Product Number
1
Dosage Form
-
Strength
333MG
Approval Date
2014-03-11
Active Ingredient
ACAMPROSATE CALCIUM
Application Number
200142
Product Number
1
Dosage Form
-
Strength
333MG
Approval Date
2014-03-11
Regulatory Status
RX
Drug Name
ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
1GM/100ML (10MG/ML)
Approval Date
2020-08-07
Active Ingredient
ACETAMINOPHEN
Application Number
213255
Product Number
1
Dosage Form
-
Strength
1GM/100ML (10MG/ML)
Approval Date
2020-08-07
Regulatory Status
RX
Drug Name
ACITRETIN
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2015-09-10
Active Ingredient
ACITRETIN
Application Number
202148
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2015-09-10
Regulatory Status
RX
Drug Name
ACITRETIN
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
2015-09-10
Active Ingredient
ACITRETIN
Application Number
202148
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
2015-09-10
Regulatory Status
RX
Drug Name
ADENOSINE
Product Number
1
Dosage Form
-
Strength
3MG/ML
Approval Date
2009-05-13
Active Ingredient
ADENOSINE
Application Number
78686
Product Number
1
Dosage Form
-
Strength
3MG/ML
Approval Date
2009-05-13
Regulatory Status
RX
Drug Name
ALLOPURINOL
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
1986-10-24
Active Ingredient
ALLOPURINOL
Application Number
18659
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
1986-10-24
Regulatory Status
RX
Drug Name
ALLOPURINOL
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
1986-10-24
Active Ingredient
ALLOPURINOL
Application Number
18659
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
1986-10-24
Regulatory Status
RX
Drug Name
ALMOTRIPTAN MALATE
Product Number
1
Dosage Form
-
Strength
EQ 6.25MG BASE
Approval Date
2015-11-09
Active Ingredient
ALMOTRIPTAN MALATE
Application Number
205171
Product Number
1
Dosage Form
-
Strength
EQ 6.25MG BASE
Approval Date
2015-11-09
Regulatory Status
RX
Drug Name
ALMOTRIPTAN MALATE
Product Number
2
Dosage Form
-
Strength
EQ 12.5MG BASE
Approval Date
2015-11-09
Active Ingredient
ALMOTRIPTAN MALATE
Application Number
205171
Product Number
2
Dosage Form
-
Strength
EQ 12.5MG BASE
Approval Date
2015-11-09
Regulatory Status
RX
Drug Name
ALOPRIM
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
1996-05-17
Active Ingredient
ALLOPURINOL SODIUM
Application Number
20298
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
1996-05-17
Regulatory Status
RX
Drug Name
AMBRISENTAN
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2019-03-28
Active Ingredient
AMBRISENTAN
Application Number
208441
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2019-03-28
Regulatory Status
RX
Drug Name
AMBRISENTAN
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2019-03-28
Active Ingredient
AMBRISENTAN
Application Number
208441
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2019-03-28
Regulatory Status
RX
Drug Name
AMIODARONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
50MG/ML
Approval Date
2002-10-15
Active Ingredient
AMIODARONE HYDROCHLORIDE
Application Number
76217
Product Number
1
Dosage Form
-
Strength
50MG/ML
Approval Date
2002-10-15
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
Product Number
4
Dosage Form
-
Strength
EQ 5MG BASE;EQ 10MG BASE
Approval Date
2013-11-29
Active Ingredient
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Application Number
200465
Product Number
4
Dosage Form
-
Strength
EQ 5MG BASE;EQ 10MG BASE
Approval Date
2013-11-29
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
Product Number
5
Dosage Form
-
Strength
EQ 5MG BASE;EQ 20MG BASE
Approval Date
2013-11-29
Active Ingredient
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Application Number
200465
Product Number
5
Dosage Form
-
Strength
EQ 5MG BASE;EQ 20MG BASE
Approval Date
2013-11-29
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
Product Number
6
Dosage Form
-
Strength
EQ 5MG BASE;EQ 40MG BASE
Approval Date
2013-11-29
Active Ingredient
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Application Number
200465
Product Number
6
Dosage Form
-
Strength
EQ 5MG BASE;EQ 40MG BASE
Approval Date
2013-11-29
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
Product Number
7
Dosage Form
-
Strength
EQ 5MG BASE;EQ 80MG BASE
Approval Date
2013-11-29
Active Ingredient
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Application Number
200465
Product Number
7
Dosage Form
-
Strength
EQ 5MG BASE;EQ 80MG BASE
Approval Date
2013-11-29
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
Product Number
8
Dosage Form
-
Strength
EQ 10MG BASE;EQ 10MG BASE
Approval Date
2013-11-29
Active Ingredient
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Application Number
200465
Product Number
8
Dosage Form
-
Strength
EQ 10MG BASE;EQ 10MG BASE
Approval Date
2013-11-29
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
Product Number
9
Dosage Form
-
Strength
EQ 10MG BASE;EQ 20MG BASE
Approval Date
2013-11-29
Active Ingredient
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Application Number
200465
Product Number
9
Dosage Form
-
Strength
EQ 10MG BASE;EQ 20MG BASE
Approval Date
2013-11-29
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
Product Number
10
Dosage Form
-
Strength
EQ 10MG BASE;EQ 40MG BASE
Approval Date
2013-11-29
Active Ingredient
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Application Number
200465
Product Number
10
Dosage Form
-
Strength
EQ 10MG BASE;EQ 40MG BASE
Approval Date
2013-11-29
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
Product Number
11
Dosage Form
-
Strength
EQ 10MG BASE;EQ 80MG BASE
Approval Date
2013-11-29
Active Ingredient
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Application Number
200465
Product Number
11
Dosage Form
-
Strength
EQ 10MG BASE;EQ 80MG BASE
Approval Date
2013-11-29
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND VALSARTAN
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE;160MG
Approval Date
2015-03-30
Active Ingredient
AMLODIPINE BESYLATE; VALSARTAN
Application Number
90483
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE;160MG
Approval Date
2015-03-30
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND VALSARTAN
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE;160MG
Approval Date
2015-03-30
Active Ingredient
AMLODIPINE BESYLATE; VALSARTAN
Application Number
90483
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE;160MG
Approval Date
2015-03-30
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND VALSARTAN
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE;320MG
Approval Date
2015-03-30
Active Ingredient
AMLODIPINE BESYLATE; VALSARTAN
Application Number
90483
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE;320MG
Approval Date
2015-03-30
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND VALSARTAN
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE;320MG
Approval Date
2015-03-30
Active Ingredient
AMLODIPINE BESYLATE; VALSARTAN
Application Number
90483
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE;320MG
Approval Date
2015-03-30
Regulatory Status
RX
Drug Name
AMNESTEEM
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2002-11-08
Active Ingredient
ISOTRETINOIN
Application Number
75945
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2002-11-08
Regulatory Status
RX
Drug Name
AMNESTEEM
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2002-11-08
Active Ingredient
ISOTRETINOIN
Application Number
75945
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2002-11-08
Regulatory Status
RX
Drug Name
AMNESTEEM
Product Number
3
Dosage Form
-
Strength
40MG
Approval Date
2002-11-08
Active Ingredient
ISOTRETINOIN
Application Number
75945
Product Number
3
Dosage Form
-
Strength
40MG
Approval Date
2002-11-08
Regulatory Status
RX
Drug Name
AMNESTEEM
Product Number
4
Dosage Form
-
Strength
30MG
Approval Date
2025-03-17
Active Ingredient
ISOTRETINOIN
Application Number
75945
Product Number
4
Dosage Form
-
Strength
30MG
Approval Date
2025-03-17
Regulatory Status
RX
Drug Name
AMPHOTERICIN B
Product Number
1
Dosage Form
-
Strength
50MG/VIAL
Approval Date
2025-06-30
Active Ingredient
AMPHOTERICIN B
Application Number
212967
Product Number
1
Dosage Form
-
Strength
50MG/VIAL
Approval Date
2025-06-30
Regulatory Status
RX
Drug Name
ARGATROBAN
Product Number
1
Dosage Form
-
Strength
250MG/2.5ML (100MG/ML)
Approval Date
2014-06-30
Active Ingredient
ARGATROBAN
Application Number
202626
Product Number
1
Dosage Form
-
Strength
250MG/2.5ML (100MG/ML)
Approval Date
2014-06-30
Regulatory Status
RX
Drug Name
ARMODAFINIL
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2012-06-01
Active Ingredient
ARMODAFINIL
Application Number
200043
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2012-06-01
Regulatory Status
RX
Drug Name
ARMODAFINIL
Product Number
2
Dosage Form
-
Strength
150MG
Approval Date
2012-06-01
Active Ingredient
ARMODAFINIL
Application Number
200043
Product Number
2
Dosage Form
-
Strength
150MG
Approval Date
2012-06-01
Regulatory Status
RX
Drug Name
ARMODAFINIL
Product Number
3
Dosage Form
-
Strength
250MG
Approval Date
2012-06-01
Active Ingredient
ARMODAFINIL
Application Number
200043
Product Number
3
Dosage Form
-
Strength
250MG
Approval Date
2012-06-01
Regulatory Status
RX
Drug Name
ARMODAFINIL
Product Number
4
Dosage Form
-
Strength
100MG
Approval Date
2019-05-09
Active Ingredient
ARMODAFINIL
Application Number
200043
Product Number
4
Dosage Form
-
Strength
100MG
Approval Date
2019-05-09
Regulatory Status
RX
Drug Name
ARMODAFINIL
Product Number
5
Dosage Form
-
Strength
200MG
Approval Date
2019-05-09
Active Ingredient
ARMODAFINIL
Application Number
200043
Product Number
5
Dosage Form
-
Strength
200MG
Approval Date
2019-05-09
Regulatory Status
RX
Drug Name
ATENOLOL
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
1992-01-24
Active Ingredient
ATENOLOL
Application Number
73457
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
1992-01-24
Regulatory Status
RX
Drug Name
ATENOLOL
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
1999-04-26
Active Ingredient
ATENOLOL
Application Number
73457
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
1999-04-26
Regulatory Status
RX
Drug Name
ATENOLOL
Product Number
3
Dosage Form
-
Strength
50MG
Approval Date
1992-01-24
Active Ingredient
ATENOLOL
Application Number
73457
Product Number
3
Dosage Form
-
Strength
50MG
Approval Date
1992-01-24
Regulatory Status
RX
Drug Name
ATORVASTATIN CALCIUM
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2012-05-29
Active Ingredient
ATORVASTATIN CALCIUM
Application Number
91226
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2012-05-29
Regulatory Status
RX
Drug Name
ATORVASTATIN CALCIUM
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2012-05-29
Active Ingredient
ATORVASTATIN CALCIUM
Application Number
91226
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2012-05-29
Regulatory Status
RX
Drug Name
ATORVASTATIN CALCIUM
Product Number
3
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2012-05-29
Active Ingredient
ATORVASTATIN CALCIUM
Application Number
91226
Product Number
3
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2012-05-29
Regulatory Status
RX
Drug Name
ATORVASTATIN CALCIUM
Product Number
4
Dosage Form
-
Strength
EQ 80MG BASE
Approval Date
2012-05-29
Active Ingredient
ATORVASTATIN CALCIUM
Application Number
91226
Product Number
4
Dosage Form
-
Strength
EQ 80MG BASE
Approval Date
2012-05-29
Regulatory Status
RX
Drug Name
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
62.5MG;25MG
Approval Date
2014-05-27
Active Ingredient
ATOVAQUONE; PROGUANIL HYDROCHLORIDE
Application Number
202362
Product Number
1
Dosage Form
-
Strength
62.5MG;25MG
Approval Date
2014-05-27
Regulatory Status
RX
Drug Name
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
250MG;100MG
Approval Date
2014-05-27
Active Ingredient
ATOVAQUONE; PROGUANIL HYDROCHLORIDE
Application Number
202362
Product Number
2
Dosage Form
-
Strength
250MG;100MG
Approval Date
2014-05-27
Regulatory Status
RX
Drug Name
AVITA
Product Number
3
Dosage Form
-
Strength
0.025%
Approval Date
1997-01-14
Active Ingredient
TRETINOIN
Application Number
20404
Product Number
3
Dosage Form
-
Strength
0.025%
Approval Date
1997-01-14
Regulatory Status
RX
Drug Name
BEPOTASTINE BESILATE
Product Number
1
Dosage Form
-
Strength
1.5%
Approval Date
2019-03-18
Active Ingredient
BEPOTASTINE BESILATE
Application Number
206220
Product Number
1
Dosage Form
-
Strength
1.5%
Approval Date
2019-03-18
Regulatory Status
RX
Drug Name
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
2.5MG;6.25MG
Approval Date
2000-09-25
Active Ingredient
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
Application Number
75768
Product Number
1
Dosage Form
-
Strength
2.5MG;6.25MG
Approval Date
2000-09-25
Regulatory Status
RX
Drug Name
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Product Number
2
Dosage Form
-
Strength
5MG;6.25MG
Approval Date
2000-09-25
Active Ingredient
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
Application Number
75768
Product Number
2
Dosage Form
-
Strength
5MG;6.25MG
Approval Date
2000-09-25
Regulatory Status
RX
Drug Name
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Product Number
3
Dosage Form
-
Strength
10MG;6.25MG
Approval Date
2000-09-25
Active Ingredient
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
Application Number
75768
Product Number
3
Dosage Form
-
Strength
10MG;6.25MG
Approval Date
2000-09-25
Regulatory Status
RX
Drug Name
BIVALIRUDIN
Product Number
1
Dosage Form
-
Strength
250MG/VIAL
Approval Date
2018-06-01
Active Ingredient
BIVALIRUDIN
Application Number
202471
Product Number
1
Dosage Form
-
Strength
250MG/VIAL
Approval Date
2018-06-01
Regulatory Status
RX
Drug Name
BREYNA
Product Number
1
Dosage Form
-
Strength
0.08MG/INH;0.0045MG/INH
Approval Date
2022-03-15
Active Ingredient
BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE
Application Number
211699
Product Number
1
Dosage Form
-
Strength
0.08MG/INH;0.0045MG/INH
Approval Date
2022-03-15
Regulatory Status
RX
Drug Name
BREYNA
Product Number
2
Dosage Form
-
Strength
0.16MG/INH;0.0045MG/INH
Approval Date
2022-03-15
Active Ingredient
BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE
Application Number
211699
Product Number
2
Dosage Form
-
Strength
0.16MG/INH;0.0045MG/INH
Approval Date
2022-03-15
Regulatory Status
RX
Drug Name
BROMOCRIPTINE MESYLATE
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2005-04-04
Active Ingredient
BROMOCRIPTINE MESYLATE
Application Number
77226
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2005-04-04
Regulatory Status
RX
Drug Name
BUDESONIDE
Product Number
1
Dosage Form
-
Strength
9MG
Approval Date
2020-09-17
Active Ingredient
BUDESONIDE
Application Number
208851
Product Number
1
Dosage Form
-
Strength
9MG
Approval Date
2020-09-17
Regulatory Status
RX
Drug Name
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 8MG BASE;EQ 2MG BASE
Approval Date
2018-06-14
Active Ingredient
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Application Number
207607
Product Number
1
Dosage Form
-
Strength
EQ 8MG BASE;EQ 2MG BASE
Approval Date
2018-06-14
Regulatory Status
RX
Drug Name
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 12MG BASE;EQ 3MG BASE
Approval Date
2018-06-14
Active Ingredient
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Application Number
207607
Product Number
2
Dosage Form
-
Strength
EQ 12MG BASE;EQ 3MG BASE
Approval Date
2018-06-14
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
2020-04-17
Active Ingredient
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Application Number
211785
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE;EQ 0.5MG BASE
Approval Date
2020-04-17
Regulatory Status
RX
Drug Name
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 4MG BASE;EQ 1MG BASE
Approval Date
2020-04-17
Active Ingredient
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Application Number
211785
Product Number
2
Dosage Form
-
Strength
EQ 4MG BASE;EQ 1MG BASE
Approval Date
2020-04-17
Regulatory Status
RX
Drug Name
BUSPIRONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
2001-06-28
Active Ingredient
BUSPIRONE HYDROCHLORIDE
Application Number
76008
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
2001-06-28
Regulatory Status
RX
Drug Name
BUSPIRONE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
5MG
Approval Date
2002-03-01
Active Ingredient
BUSPIRONE HYDROCHLORIDE
Application Number
76008
Product Number
3
Dosage Form
-
Strength
5MG
Approval Date
2002-03-01
Regulatory Status
RX
Drug Name
BUSPIRONE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
10MG
Approval Date
2002-03-01
Active Ingredient
BUSPIRONE HYDROCHLORIDE
Application Number
76008
Product Number
4
Dosage Form
-
Strength
10MG
Approval Date
2002-03-01
Regulatory Status
RX
Drug Name
BUSPIRONE HYDROCHLORIDE
Product Number
5
Dosage Form
-
Strength
15MG
Approval Date
2001-03-28
Active Ingredient
BUSPIRONE HYDROCHLORIDE
Application Number
76008
Product Number
5
Dosage Form
-
Strength
15MG
Approval Date
2001-03-28
Regulatory Status
RX
Drug Name
CANDESARTAN CILEXETIL
Product Number
1
Dosage Form
-
Strength
4MG
Approval Date
2013-05-03
Active Ingredient
CANDESARTAN CILEXETIL
Application Number
78702
Product Number
1
Dosage Form
-
Strength
4MG
Approval Date
2013-05-03
Regulatory Status
RX
Drug Name
CANDESARTAN CILEXETIL
Product Number
2
Dosage Form
-
Strength
8MG
Approval Date
2013-05-03
Active Ingredient
CANDESARTAN CILEXETIL
Application Number
78702
Product Number
2
Dosage Form
-
Strength
8MG
Approval Date
2013-05-03
Regulatory Status
RX
Drug Name
CANDESARTAN CILEXETIL
Product Number
3
Dosage Form
-
Strength
16MG
Approval Date
2013-05-03
Active Ingredient
CANDESARTAN CILEXETIL
Application Number
78702
Product Number
3
Dosage Form
-
Strength
16MG
Approval Date
2013-05-03
Regulatory Status
RX
Drug Name
CANDESARTAN CILEXETIL
Product Number
4
Dosage Form
-
Strength
32MG
Approval Date
2013-05-03
Active Ingredient
CANDESARTAN CILEXETIL
Application Number
78702
Product Number
4
Dosage Form
-
Strength
32MG
Approval Date
2013-05-03
Regulatory Status
RX
Drug Name
CARBIDOPA AND LEVODOPA
Product Number
1
Dosage Form
-
Strength
50MG;200MG
Approval Date
1999-09-30
Active Ingredient
CARBIDOPA; LEVODOPA
Application Number
75091
Product Number
1
Dosage Form
-
Strength
50MG;200MG
Approval Date
1999-09-30
Regulatory Status
RX
Drug Name
CARBIDOPA AND LEVODOPA
Product Number
2
Dosage Form
-
Strength
25MG;100MG
Approval Date
2000-04-21
Active Ingredient
CARBIDOPA; LEVODOPA
Application Number
75091
Product Number
2
Dosage Form
-
Strength
25MG;100MG
Approval Date
2000-04-21
Regulatory Status
RX
Drug Name
CARDURA
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
1990-11-02
Active Ingredient
DOXAZOSIN MESYLATE
Application Number
19668
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
1990-11-02
Regulatory Status
RX
Drug Name
CARDURA
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
1990-11-02
Active Ingredient
DOXAZOSIN MESYLATE
Application Number
19668
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
1990-11-02
Regulatory Status
RX
Drug Name
CARDURA
Product Number
3
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
1990-11-02
Active Ingredient
DOXAZOSIN MESYLATE
Application Number
19668
Product Number
3
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
1990-11-02
Regulatory Status
RX
Drug Name
CARDURA
Product Number
4
Dosage Form
-
Strength
EQ 8MG BASE
Approval Date
1990-11-02
Active Ingredient
DOXAZOSIN MESYLATE
Application Number
19668
Product Number
4
Dosage Form
-
Strength
EQ 8MG BASE
Approval Date
1990-11-02
Regulatory Status
RX
Drug Name
CARDURA XL
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2005-02-22
Active Ingredient
DOXAZOSIN MESYLATE
Application Number
21269
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2005-02-22
Regulatory Status
RX
Drug Name
CARDURA XL
Product Number
2
Dosage Form
-
Strength
EQ 8MG BASE
Approval Date
2005-02-22
Active Ingredient
DOXAZOSIN MESYLATE
Application Number
21269
Product Number
2
Dosage Form
-
Strength
EQ 8MG BASE
Approval Date
2005-02-22
Regulatory Status
RX
Drug Name
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE;10MG
Approval Date
1986-12-10
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE
Application Number
71297
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE;10MG
Approval Date
1986-12-10
Regulatory Status
RX
Drug Name
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 12.5MG BASE;5MG
Approval Date
1986-12-10
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE
Application Number
71297
Product Number
2
Dosage Form
-
Strength
EQ 12.5MG BASE;5MG
Approval Date
1986-12-10
Regulatory Status
RX
Drug Name
CHLORTHALIDONE
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
1982-01-01
Active Ingredient
CHLORTHALIDONE
Application Number
86831
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
CHLORTHALIDONE
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
1982-01-01
Active Ingredient
CHLORTHALIDONE
Application Number
86831
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
CIDOFOVIR
Product Number
1
Dosage Form
-
Strength
EQ 375MG BASE/5ML (EQ 75MG BASE/ML)
Approval Date
2012-06-27
Active Ingredient
CIDOFOVIR
Application Number
201276
Product Number
1
Dosage Form
-
Strength
EQ 375MG BASE/5ML (EQ 75MG BASE/ML)
Approval Date
2012-06-27
Regulatory Status
RX
Drug Name
CIMDUO
Product Number
1
Dosage Form
-
Strength
300MG;300MG
Approval Date
2018-02-28
Active Ingredient
LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
Application Number
22141
Product Number
1
Dosage Form
-
Strength
300MG;300MG
Approval Date
2018-02-28
Regulatory Status
RX
Drug Name
CIMETIDINE
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
1994-05-17
Active Ingredient
CIMETIDINE
Application Number
74246
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
1994-05-17
Regulatory Status
RX
Drug Name
CIMETIDINE
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
1994-05-17
Active Ingredient
CIMETIDINE
Application Number
74246
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
1994-05-17
Regulatory Status
RX
Drug Name
CIMETIDINE
Product Number
3
Dosage Form
-
Strength
400MG
Approval Date
1994-05-17
Active Ingredient
CIMETIDINE
Application Number
74246
Product Number
3
Dosage Form
-
Strength
400MG
Approval Date
1994-05-17
Regulatory Status
RX
Drug Name
CIMETIDINE
Product Number
4
Dosage Form
-
Strength
800MG
Approval Date
1994-05-17
Active Ingredient
CIMETIDINE
Application Number
74246
Product Number
4
Dosage Form
-
Strength
800MG
Approval Date
1994-05-17
Regulatory Status
RX
Drug Name
CITALOPRAM HYDROBROMIDE
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2004-11-05
Active Ingredient
CITALOPRAM HYDROBROMIDE
Application Number
77042
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2004-11-05
Regulatory Status
RX
Drug Name
CITALOPRAM HYDROBROMIDE
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2004-11-05
Active Ingredient
CITALOPRAM HYDROBROMIDE
Application Number
77042
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2004-11-05
Regulatory Status
RX
Drug Name
CITALOPRAM HYDROBROMIDE
Product Number
3
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2004-11-05
Active Ingredient
CITALOPRAM HYDROBROMIDE
Application Number
77042
Product Number
3
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2004-11-05
Regulatory Status
RX
Drug Name
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
Product Number
1
Dosage Form
-
Strength
5%;EQ 1% BASE
Approval Date
2009-08-11
Active Ingredient
BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
Application Number
65443
Product Number
1
Dosage Form
-
Strength
5%;EQ 1% BASE
Approval Date
2009-08-11
Regulatory Status
RX
Drug Name
CLONIDINE
Product Number
1
Dosage Form
-
Strength
0.1MG/24HR
Approval Date
2010-07-16
Active Ingredient
CLONIDINE
Application Number
76166
Product Number
1
Dosage Form
-
Strength
0.1MG/24HR
Approval Date
2010-07-16
Regulatory Status
RX
Drug Name
CLONIDINE
Product Number
2
Dosage Form
-
Strength
0.2MG/24HR
Approval Date
2010-07-16
Active Ingredient
CLONIDINE
Application Number
76166
Product Number
2
Dosage Form
-
Strength
0.2MG/24HR
Approval Date
2010-07-16
Regulatory Status
RX
Drug Name
CLONIDINE
Product Number
3
Dosage Form
-
Strength
0.3MG/24HR
Approval Date
2010-07-16
Active Ingredient
CLONIDINE
Application Number
76166
Product Number
3
Dosage Form
-
Strength
0.3MG/24HR
Approval Date
2010-07-16
Regulatory Status
RX
Drug Name
CLOZAPINE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1999-05-27
Active Ingredient
CLOZAPINE
Application Number
75417
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1999-05-27
Regulatory Status
RX
Drug Name
CLOZAPINE
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
1999-05-27
Active Ingredient
CLOZAPINE
Application Number
75417
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
1999-05-27
Regulatory Status
RX
Drug Name
CLOZAPINE
Product Number
4
Dosage Form
-
Strength
50MG
Approval Date
2010-04-15
Active Ingredient
CLOZAPINE
Application Number
75417
Product Number
4
Dosage Form
-
Strength
50MG
Approval Date
2010-04-15
Regulatory Status
RX
Drug Name
CLOZAPINE
Product Number
5
Dosage Form
-
Strength
200MG
Approval Date
2010-04-15
Active Ingredient
CLOZAPINE
Application Number
75417
Product Number
5
Dosage Form
-
Strength
200MG
Approval Date
2010-04-15
Regulatory Status
RX
Drug Name
CLOZAPINE
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
2015-09-15
Active Ingredient
CLOZAPINE
Application Number
201824
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
2015-09-15
Regulatory Status
RX
Drug Name
CLOZAPINE
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2015-09-15
Active Ingredient
CLOZAPINE
Application Number
201824
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2015-09-15
Regulatory Status
RX
Drug Name
CLOZAPINE
Product Number
4
Dosage Form
-
Strength
150MG
Approval Date
2023-08-07
Active Ingredient
CLOZAPINE
Application Number
201824
Product Number
4
Dosage Form
-
Strength
150MG
Approval Date
2023-08-07
Regulatory Status
RX
Drug Name
CLOZAPINE
Product Number
5
Dosage Form
-
Strength
200MG
Approval Date
2023-08-07
Active Ingredient
CLOZAPINE
Application Number
201824
Product Number
5
Dosage Form
-
Strength
200MG
Approval Date
2023-08-07
Regulatory Status
RX
Drug Name
COLCHICINE
Product Number
1
Dosage Form
-
Strength
0.6MG
Approval Date
2019-09-16
Active Ingredient
COLCHICINE
Application Number
209470
Product Number
1
Dosage Form
-
Strength
0.6MG
Approval Date
2019-09-16
Regulatory Status
RX
Drug Name
CORTIFOAM
Product Number
1
Dosage Form
-
Strength
10%
Approval Date
1982-02-10
Active Ingredient
HYDROCORTISONE ACETATE
Application Number
17351
Product Number
1
Dosage Form
-
Strength
10%
Approval Date
1982-02-10
Regulatory Status
RX
Drug Name
CYCLOSPORINE
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2022-02-02
Active Ingredient
CYCLOSPORINE
Application Number
205894
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2022-02-02
Regulatory Status
RX
Drug Name
CYSTAGON
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
1994-08-15
Active Ingredient
CYSTEAMINE BITARTRATE
Application Number
20392
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
1994-08-15
Regulatory Status
RX
Drug Name
CYSTAGON
Product Number
2
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
1994-08-15
Active Ingredient
CYSTEAMINE BITARTRATE
Application Number
20392
Product Number
2
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
1994-08-15
Regulatory Status
RX
Drug Name
DABIGATRAN ETEXILATE MESYLATE
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2025-02-03
Active Ingredient
DABIGATRAN ETEXILATE MESYLATE
Application Number
208067
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2025-02-03
Regulatory Status
RX
Drug Name
DABIGATRAN ETEXILATE MESYLATE
Product Number
2
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2025-02-03
Active Ingredient
DABIGATRAN ETEXILATE MESYLATE
Application Number
208067
Product Number
2
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2025-02-03
Regulatory Status
RX
Drug Name
DAPSONE
Product Number
1
Dosage Form
-
Strength
7.5%
Approval Date
2022-02-04
Active Ingredient
DAPSONE
Application Number
213847
Product Number
1
Dosage Form
-
Strength
7.5%
Approval Date
2022-02-04
Regulatory Status
RX
Drug Name
DAPTOMYCIN
Product Number
1
Dosage Form
-
Strength
500MG/VIAL
Approval Date
2018-06-05
Active Ingredient
DAPTOMYCIN
Application Number
205037
Product Number
1
Dosage Form
-
Strength
500MG/VIAL
Approval Date
2018-06-05
Regulatory Status
RX
Drug Name
DAPTOMYCIN
Product Number
1
Dosage Form
-
Strength
500MG/VIAL
Approval Date
2023-08-07
Active Ingredient
DAPTOMYCIN
Application Number
213966
Product Number
1
Dosage Form
-
Strength
500MG/VIAL
Approval Date
2023-08-07
Regulatory Status
RX
Drug Name
DARUNAVIR
Product Number
1
Dosage Form
-
Strength
75MG
Approval Date
2025-07-22
Active Ingredient
DARUNAVIR
Application Number
202136
Product Number
1
Dosage Form
-
Strength
75MG
Approval Date
2025-07-22
Regulatory Status
RX
Drug Name
DARUNAVIR
Product Number
2
Dosage Form
-
Strength
150MG
Approval Date
2025-07-22
Active Ingredient
DARUNAVIR
Application Number
202136
Product Number
2
Dosage Form
-
Strength
150MG
Approval Date
2025-07-22
Regulatory Status
RX
Drug Name
DARUNAVIR
Product Number
3
Dosage Form
-
Strength
300MG
Approval Date
2025-07-22
Active Ingredient
DARUNAVIR
Application Number
202136
Product Number
3
Dosage Form
-
Strength
300MG
Approval Date
2025-07-22
Regulatory Status
RX
Drug Name
DARUNAVIR
Product Number
4
Dosage Form
-
Strength
400MG
Approval Date
2025-07-22
Active Ingredient
DARUNAVIR
Application Number
202136
Product Number
4
Dosage Form
-
Strength
400MG
Approval Date
2025-07-22
Regulatory Status
RX
Drug Name
DARUNAVIR
Product Number
5
Dosage Form
-
Strength
600MG
Approval Date
2025-07-22
Active Ingredient
DARUNAVIR
Application Number
202136
Product Number
5
Dosage Form
-
Strength
600MG
Approval Date
2025-07-22
Regulatory Status
RX
Drug Name
DENAVIR
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
1996-09-24
Active Ingredient
PENCICLOVIR
Application Number
20629
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
1996-09-24
Regulatory Status
RX
Drug Name
DEPEN
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
1982-01-01
Active Ingredient
PENICILLAMINE
Application Number
19854
Product Number
1
Dosage Form
-
Strength
250MG
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
2008-08-29
Active Ingredient
DEXAMETHASONE SODIUM PHOSPHATE
Application Number
40802
Product Number
1
Dosage Form
-
Strength
EQ 10MG PHOSPHATE/ML
Approval Date
2008-08-29
Regulatory Status
RX
Drug Name
DEXAMETHASONE SODIUM PHOSPHATE
Product Number
1
Dosage Form
-
Strength
EQ 4MG PHOSPHATE/ML
Approval Date
2008-08-29
Active Ingredient
DEXAMETHASONE SODIUM PHOSPHATE
Application Number
40803
Product Number
1
Dosage Form
-
Strength
EQ 4MG PHOSPHATE/ML
Approval Date
2008-08-29
Regulatory Status
RX
Drug Name
DEXLANSOPRAZOLE
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
2024-01-19
Active Ingredient
DEXLANSOPRAZOLE
Application Number
205205
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
2024-01-19
Regulatory Status
RX
Drug Name
DEXLANSOPRAZOLE
Product Number
2
Dosage Form
-
Strength
60MG
Approval Date
2024-01-19
Active Ingredient
DEXLANSOPRAZOLE
Application Number
205205
Product Number
2
Dosage Form
-
Strength
60MG
Approval Date
2024-01-19
Regulatory Status
RX
Drug Name
DEXMEDETOMIDINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)
Approval Date
2014-08-18
Active Ingredient
DEXMEDETOMIDINE HYDROCHLORIDE
Application Number
202881
Product Number
1
Dosage Form
-
Strength
EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)
Approval Date
2014-08-18
Regulatory Status
RX
Drug Name
DEXMEDETOMIDINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)
Approval Date
2020-08-27
Active Ingredient
DEXMEDETOMIDINE HYDROCHLORIDE
Application Number
212571
Product Number
1
Dosage Form
-
Strength
EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)
Approval Date
2020-08-27
Regulatory Status
RX
Drug Name
DEXMEDETOMIDINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)
Approval Date
2020-08-27
Active Ingredient
DEXMEDETOMIDINE HYDROCHLORIDE
Application Number
212571
Product Number
2
Dosage Form
-
Strength
EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)
Approval Date
2020-08-27
Regulatory Status
RX
Drug Name
DIAZEPAM
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1985-09-04
Active Ingredient
DIAZEPAM
Application Number
70325
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1985-09-04
Regulatory Status
RX
Drug Name
DIAZEPAM
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
1985-09-04
Active Ingredient
DIAZEPAM
Application Number
70325
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
1985-09-04
Regulatory Status
RX
Drug Name
DIAZEPAM
Product Number
3
Dosage Form
-
Strength
5MG
Approval Date
1985-09-04
Active Ingredient
DIAZEPAM
Application Number
70325
Product Number
3
Dosage Form
-
Strength
5MG
Approval Date
1985-09-04
Regulatory Status
RX
Drug Name
DIFLUPREDNATE
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2025-03-20
Active Ingredient
DIFLUPREDNATE
Application Number
212566
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2025-03-20
Regulatory Status
RX
Drug Name
DILANTIN
Product Number
1
Dosage Form
-
Strength
30MG EXTENDED
Approval Date
1982-01-01
Active Ingredient
PHENYTOIN SODIUM
Application Number
84349
Product Number
1
Dosage Form
-
Strength
30MG EXTENDED
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
DILANTIN
Product Number
2
Dosage Form
-
Strength
100MG EXTENDED
Approval Date
1982-01-01
Active Ingredient
PHENYTOIN SODIUM
Application Number
84349
Product Number
2
Dosage Form
-
Strength
100MG EXTENDED
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
DILANTIN-125
Product Number
1
Dosage Form
-
Strength
125MG/5ML
Approval Date
1982-01-01
Active Ingredient
PHENYTOIN
Application Number
8762
Product Number
1
Dosage Form
-
Strength
125MG/5ML
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
DILTIAZEM HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
60MG
Approval Date
1997-05-02
Active Ingredient
DILTIAZEM HYDROCHLORIDE
Application Number
74910
Product Number
1
Dosage Form
-
Strength
60MG
Approval Date
1997-05-02
Regulatory Status
RX
Drug Name
DILTIAZEM HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
90MG
Approval Date
1997-05-02
Active Ingredient
DILTIAZEM HYDROCHLORIDE
Application Number
74910
Product Number
2
Dosage Form
-
Strength
90MG
Approval Date
1997-05-02
Regulatory Status
RX
Drug Name
DILTIAZEM HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
120MG
Approval Date
1997-05-02
Active Ingredient
DILTIAZEM HYDROCHLORIDE
Application Number
74910
Product Number
3
Dosage Form
-
Strength
120MG
Approval Date
1997-05-02
Regulatory Status
RX
Drug Name
DIVALPROEX SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 250MG VALPROIC ACID
Approval Date
2009-01-29
Active Ingredient
DIVALPROEX SODIUM
Application Number
77567
Product Number
1
Dosage Form
-
Strength
EQ 250MG VALPROIC ACID
Approval Date
2009-01-29
Regulatory Status
RX
Drug Name
DIVALPROEX SODIUM
Product Number
2
Dosage Form
-
Strength
EQ 500MG VALPROIC ACID
Approval Date
2009-01-29
Active Ingredient
DIVALPROEX SODIUM
Application Number
77567
Product Number
2
Dosage Form
-
Strength
EQ 500MG VALPROIC ACID
Approval Date
2009-01-29
Regulatory Status
RX
Drug Name
DOCETAXEL
Product Number
1
Dosage Form
-
Strength
160MG/8ML (20MG/ML)
Approval Date
2019-04-01
Active Ingredient
DOCETAXEL
Application Number
208137
Product Number
1
Dosage Form
-
Strength
160MG/8ML (20MG/ML)
Approval Date
2019-04-01
Regulatory Status
RX
Drug Name
DOCETAXEL
Product Number
1
Dosage Form
-
Strength
160MG/16ML (10MG/ML)
Approval Date
2018-04-30
Active Ingredient
DOCETAXEL
Application Number
208859
Product Number
1
Dosage Form
-
Strength
160MG/16ML (10MG/ML)
Approval Date
2018-04-30
Regulatory Status
RX
Drug Name
DOCETAXEL
Product Number
1
Dosage Form
-
Strength
20MG/2ML (10MG/ML)
Approval Date
2018-07-02
Active Ingredient
DOCETAXEL
Application Number
210072
Product Number
1
Dosage Form
-
Strength
20MG/2ML (10MG/ML)
Approval Date
2018-07-02
Regulatory Status
RX
Drug Name
DOCETAXEL
Product Number
1
Dosage Form
-
Strength
80MG/8ML (10MG/ML)
Approval Date
2018-07-06
Active Ingredient
DOCETAXEL
Application Number
210848
Product Number
1
Dosage Form
-
Strength
80MG/8ML (10MG/ML)
Approval Date
2018-07-06
Regulatory Status
RX
Drug Name
DOXEPIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
1986-05-13
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
70791
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
1986-05-13
Regulatory Status
RX
Drug Name
DOXEPIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
1986-05-13
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
70791
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
1986-05-13
Regulatory Status
RX
Drug Name
DOXEPIN HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
1986-05-13
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
70791
Product Number
3
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
1986-05-13
Regulatory Status
RX
Drug Name
DOXEPIN HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
1986-05-13
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
70791
Product Number
4
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
1986-05-13
Regulatory Status
RX
Drug Name
DOXEPIN HYDROCHLORIDE
Product Number
5
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
1986-05-13
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
70791
Product Number
5
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
1986-05-13
Regulatory Status
RX
Drug Name
DOXORUBICIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
50MG/VIAL
Approval Date
2011-10-28
Active Ingredient
DOXORUBICIN HYDROCHLORIDE
Application Number
200170
Product Number
2
Dosage Form
-
Strength
50MG/VIAL
Approval Date
2011-10-28
Regulatory Status
RX
Drug Name
DOXYCYCLINE
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE/VIAL
Approval Date
2012-08-21
Active Ingredient
DOXYCYCLINE HYCLATE
Application Number
91406
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE/VIAL
Approval Date
2012-08-21
Regulatory Status
RX
Drug Name
DURACLON
Product Number
1
Dosage Form
-
Strength
1MG/10ML (0.1MG/ML)
Approval Date
1996-10-02
Active Ingredient
CLONIDINE HYDROCHLORIDE
Application Number
20615
Product Number
1
Dosage Form
-
Strength
1MG/10ML (0.1MG/ML)
Approval Date
1996-10-02
Regulatory Status
RX
Drug Name
DYMISTA
Product Number
1
Dosage Form
-
Strength
0.137MG/SPRAY;0.05MG/SPRAY
Approval Date
2012-05-01
Active Ingredient
AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE
Application Number
202236
Product Number
1
Dosage Form
-
Strength
0.137MG/SPRAY;0.05MG/SPRAY
Approval Date
2012-05-01
Regulatory Status
RX
Drug Name
EDLUAR
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2009-03-13
Active Ingredient
ZOLPIDEM TARTRATE
Application Number
21997
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2009-03-13
Regulatory Status
RX
Drug Name
EDLUAR
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2009-03-13
Active Ingredient
ZOLPIDEM TARTRATE
Application Number
21997
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2009-03-13
Regulatory Status
RX
Drug Name
ELESTRIN
Product Number
1
Dosage Form
-
Strength
0.06% (0.87GM/ACTIVATION)
Approval Date
2006-12-15
Active Ingredient
ESTRADIOL
Application Number
21813
Product Number
1
Dosage Form
-
Strength
0.06% (0.87GM/ACTIVATION)
Approval Date
2006-12-15
Regulatory Status
RX
Drug Name
ELETRIPTAN HYDROBROMIDE
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2017-08-11
Active Ingredient
ELETRIPTAN HYDROBROMIDE
Application Number
205152
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2017-08-11
Regulatory Status
RX
Drug Name
ELETRIPTAN HYDROBROMIDE
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2017-08-11
Active Ingredient
ELETRIPTAN HYDROBROMIDE
Application Number
205152
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2017-08-11
Regulatory Status
RX
Drug Name
EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE
Product Number
1
Dosage Form
-
Strength
200MG;EQ 25MG BASE;300MG
Approval Date
2025-05-20
Active Ingredient
EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE
Application Number
208452
Product Number
1
Dosage Form
-
Strength
200MG;EQ 25MG BASE;300MG
Approval Date
2025-05-20
Regulatory Status
RX
Drug Name
EPIFOAM
Product Number
1
Dosage Form
-
Strength
1%;1%
Approval Date
1982-01-01
Active Ingredient
HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE
Application Number
86457
Product Number
1
Dosage Form
-
Strength
1%;1%
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
EPIPEN
Product Number
1
Dosage Form
-
Strength
0.3MG/DELIVERY
Approval Date
1987-12-22
Active Ingredient
EPINEPHRINE
Application Number
19430
Product Number
1
Dosage Form
-
Strength
0.3MG/DELIVERY
Approval Date
1987-12-22
Regulatory Status
RX
Drug Name
EPIPEN JR.
Product Number
2
Dosage Form
-
Strength
0.15MG/DELIVERY
Approval Date
1987-12-22
Active Ingredient
EPINEPHRINE
Application Number
19430
Product Number
2
Dosage Form
-
Strength
0.15MG/DELIVERY
Approval Date
1987-12-22
Regulatory Status
RX
Drug Name
EPOPROSTENOL SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 0.5MG BASE/VIAL
Approval Date
2024-06-12
Active Ingredient
EPOPROSTENOL SODIUM
Application Number
213913
Product Number
1
Dosage Form
-
Strength
EQ 0.5MG BASE/VIAL
Approval Date
2024-06-12
Regulatory Status
RX
Drug Name
EPOPROSTENOL SODIUM
Product Number
2
Dosage Form
-
Strength
EQ 1.5MG BASE/VIAL
Approval Date
2024-06-12
Active Ingredient
EPOPROSTENOL SODIUM
Application Number
213913
Product Number
2
Dosage Form
-
Strength
EQ 1.5MG BASE/VIAL
Approval Date
2024-06-12
Regulatory Status
RX
Drug Name
EPTIFIBATIDE
Product Number
1
Dosage Form
-
Strength
2MG/ML
Approval Date
2018-07-20
Active Ingredient
EPTIFIBATIDE
Application Number
203258
Product Number
1
Dosage Form
-
Strength
2MG/ML
Approval Date
2018-07-20
Regulatory Status
RX
Drug Name
EPTIFIBATIDE
Product Number
2
Dosage Form
-
Strength
75MG/100ML
Approval Date
2018-07-20
Active Ingredient
EPTIFIBATIDE
Application Number
203258
Product Number
2
Dosage Form
-
Strength
75MG/100ML
Approval Date
2018-07-20
Regulatory Status
RX
Drug Name
ERMEZA
Product Number
1
Dosage Form
-
Strength
150MCG/5ML
Approval Date
2022-04-29
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
215809
Product Number
1
Dosage Form
-
Strength
150MCG/5ML
Approval Date
2022-04-29
Regulatory Status
RX
Drug Name
ESMOLOL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2005-05-02
Active Ingredient
ESMOLOL HYDROCHLORIDE
Application Number
76474
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2005-05-02
Regulatory Status
RX
Drug Name
ESMOLOL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
1GM/100ML
Approval Date
2018-06-08
Active Ingredient
ESMOLOL HYDROCHLORIDE
Application Number
206608
Product Number
1
Dosage Form
-
Strength
1GM/100ML
Approval Date
2018-06-08
Regulatory Status
RX
Drug Name
ESMOLOL HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
2GM/100ML
Approval Date
2018-06-08
Active Ingredient
ESMOLOL HYDROCHLORIDE
Application Number
206608
Product Number
2
Dosage Form
-
Strength
2GM/100ML
Approval Date
2018-06-08
Regulatory Status
RX
Drug Name
ESOMEPRAZOLE MAGNESIUM
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2015-08-02
Active Ingredient
ESOMEPRAZOLE MAGNESIUM
Application Number
78936
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2015-08-02
Regulatory Status
RX
Drug Name
ESOMEPRAZOLE MAGNESIUM
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2015-08-03
Active Ingredient
ESOMEPRAZOLE MAGNESIUM
Application Number
78936
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2015-08-03
Regulatory Status
RX
Drug Name
ESTRADIOL
Product Number
1
Dosage Form
-
Strength
0.1MG/24HR
Approval Date
2000-02-24
Active Ingredient
ESTRADIOL
Application Number
75182
Product Number
1
Dosage Form
-
Strength
0.1MG/24HR
Approval Date
2000-02-24
Regulatory Status
RX
Drug Name
ESTRADIOL
Product Number
2
Dosage Form
-
Strength
0.075MG/24HR
Approval Date
2005-01-26
Active Ingredient
ESTRADIOL
Application Number
75182
Product Number
2
Dosage Form
-
Strength
0.075MG/24HR
Approval Date
2005-01-26
Regulatory Status
RX
Drug Name
ESTRADIOL
Product Number
3
Dosage Form
-
Strength
0.025MG/24HR
Approval Date
2005-01-26
Active Ingredient
ESTRADIOL
Application Number
75182
Product Number
3
Dosage Form
-
Strength
0.025MG/24HR
Approval Date
2005-01-26
Regulatory Status
RX
Drug Name
ESTRADIOL
Product Number
4
Dosage Form
-
Strength
0.0375MG/24HR
Approval Date
2006-07-20
Active Ingredient
ESTRADIOL
Application Number
75182
Product Number
4
Dosage Form
-
Strength
0.0375MG/24HR
Approval Date
2006-07-20
Regulatory Status
RX
Drug Name
ESTRADIOL
Product Number
5
Dosage Form
-
Strength
0.06MG/24HR
Approval Date
2006-07-20
Active Ingredient
ESTRADIOL
Application Number
75182
Product Number
5
Dosage Form
-
Strength
0.06MG/24HR
Approval Date
2006-07-20
Regulatory Status
RX
Drug Name
ESTRADIOL
Product Number
6
Dosage Form
-
Strength
0.05MG/24HR
Approval Date
2000-02-24
Active Ingredient
ESTRADIOL
Application Number
75182
Product Number
6
Dosage Form
-
Strength
0.05MG/24HR
Approval Date
2000-02-24
Regulatory Status
RX
Drug Name
ESTRADIOL
Product Number
1
Dosage Form
-
Strength
0.025MG/24HR
Approval Date
2014-12-19
Active Ingredient
ESTRADIOL
Application Number
201675
Product Number
1
Dosage Form
-
Strength
0.025MG/24HR
Approval Date
2014-12-19
Regulatory Status
RX
Drug Name
ESTRADIOL
Product Number
2
Dosage Form
-
Strength
0.0375MG/24HR
Approval Date
2014-12-19
Active Ingredient
ESTRADIOL
Application Number
201675
Product Number
2
Dosage Form
-
Strength
0.0375MG/24HR
Approval Date
2014-12-19
Regulatory Status
RX
Drug Name
ESTRADIOL
Product Number
3
Dosage Form
-
Strength
0.05MG/24HR
Approval Date
2014-12-19
Active Ingredient
ESTRADIOL
Application Number
201675
Product Number
3
Dosage Form
-
Strength
0.05MG/24HR
Approval Date
2014-12-19
Regulatory Status
RX
Drug Name
ESTRADIOL
Product Number
4
Dosage Form
-
Strength
0.075MG/24HR
Approval Date
2014-12-19
Active Ingredient
ESTRADIOL
Application Number
201675
Product Number
4
Dosage Form
-
Strength
0.075MG/24HR
Approval Date
2014-12-19
Regulatory Status
RX
Drug Name
ESTRADIOL
Product Number
5
Dosage Form
-
Strength
0.1MG/24HR
Approval Date
2014-12-19
Active Ingredient
ESTRADIOL
Application Number
201675
Product Number
5
Dosage Form
-
Strength
0.1MG/24HR
Approval Date
2014-12-19
Regulatory Status
RX
Drug Name
ESTRADIOL
Product Number
1
Dosage Form
-
Strength
0.025MG/24HR
Approval Date
2018-08-15
Active Ingredient
ESTRADIOL
Application Number
206685
Product Number
1
Dosage Form
-
Strength
0.025MG/24HR
Approval Date
2018-08-15
Regulatory Status
RX
Drug Name
ESTRADIOL
Product Number
2
Dosage Form
-
Strength
0.0375MG/24HR
Approval Date
2018-08-15
Active Ingredient
ESTRADIOL
Application Number
206685
Product Number
2
Dosage Form
-
Strength
0.0375MG/24HR
Approval Date
2018-08-15
Regulatory Status
RX
Drug Name
ESTRADIOL
Product Number
3
Dosage Form
-
Strength
0.05MG/24HR
Approval Date
2018-08-15
Active Ingredient
ESTRADIOL
Application Number
206685
Product Number
3
Dosage Form
-
Strength
0.05MG/24HR
Approval Date
2018-08-15
Regulatory Status
RX
Drug Name
ESTRADIOL
Product Number
4
Dosage Form
-
Strength
0.075MG/24HR
Approval Date
2018-08-15
Active Ingredient
ESTRADIOL
Application Number
206685
Product Number
4
Dosage Form
-
Strength
0.075MG/24HR
Approval Date
2018-08-15
Regulatory Status
RX
Drug Name
ESTRADIOL
Product Number
5
Dosage Form
-
Strength
0.1MG/24HR
Approval Date
2018-08-15
Active Ingredient
ESTRADIOL
Application Number
206685
Product Number
5
Dosage Form
-
Strength
0.1MG/24HR
Approval Date
2018-08-15
Regulatory Status
RX
Drug Name
ESTRADIOL
Product Number
1
Dosage Form
-
Strength
0.01%
Approval Date
2017-12-29
Active Ingredient
ESTRADIOL
Application Number
208788
Product Number
1
Dosage Form
-
Strength
0.01%
Approval Date
2017-12-29
Regulatory Status
RX
Drug Name
ESZOPICLONE
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2013-03-26
Active Ingredient
ESZOPICLONE
Application Number
91151
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2013-03-26
Regulatory Status
RX
Drug Name
ESZOPICLONE
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
2013-03-26
Active Ingredient
ESZOPICLONE
Application Number
91151
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
2013-03-26
Regulatory Status
RX
Drug Name
ESZOPICLONE
Product Number
3
Dosage Form
-
Strength
3MG
Approval Date
2013-03-26
Active Ingredient
ESZOPICLONE
Application Number
91151
Product Number
3
Dosage Form
-
Strength
3MG
Approval Date
2013-03-26
Regulatory Status
RX
Drug Name
ETOMIDATE
Product Number
1
Dosage Form
-
Strength
2MG/ML
Approval Date
2017-02-07
Active Ingredient
ETOMIDATE
Application Number
201044
Product Number
1
Dosage Form
-
Strength
2MG/ML
Approval Date
2017-02-07
Regulatory Status
RX
Drug Name
ETOPOSIDE
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2001-09-19
Active Ingredient
ETOPOSIDE
Application Number
75635
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2001-09-19
Regulatory Status
RX
Drug Name
FAMOTIDINE
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2008-06-25
Active Ingredient
FAMOTIDINE
Application Number
78641
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2008-06-25
Regulatory Status
RX
Drug Name
FAMOTIDINE PRESERVATIVE FREE
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2008-06-25
Active Ingredient
FAMOTIDINE
Application Number
78642
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2008-06-25
Regulatory Status
RX
Drug Name
FELBATOL
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
1993-07-29
Active Ingredient
FELBAMATE
Application Number
20189
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
1993-07-29
Regulatory Status
RX
Drug Name
FELBATOL
Product Number
2
Dosage Form
-
Strength
600MG
Approval Date
1993-07-29
Active Ingredient
FELBAMATE
Application Number
20189
Product Number
2
Dosage Form
-
Strength
600MG
Approval Date
1993-07-29
Regulatory Status
RX
Drug Name
FENOFIBRATE
Product Number
1
Dosage Form
-
Strength
48MG
Approval Date
2012-12-07
Active Ingredient
FENOFIBRATE
Application Number
202856
Product Number
1
Dosage Form
-
Strength
48MG
Approval Date
2012-12-07
Regulatory Status
RX
Drug Name
FENOFIBRATE
Product Number
2
Dosage Form
-
Strength
145MG
Approval Date
2012-12-07
Active Ingredient
FENOFIBRATE
Application Number
202856
Product Number
2
Dosage Form
-
Strength
145MG
Approval Date
2012-12-07
Regulatory Status
RX
Drug Name
FENOFIBRATE
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
2016-06-23
Active Ingredient
FENOFIBRATE
Application Number
204475
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
2016-06-23
Regulatory Status
RX
Drug Name
FENOFIBRATE
Product Number
2
Dosage Form
-
Strength
120MG
Approval Date
2016-06-23
Active Ingredient
FENOFIBRATE
Application Number
204475
Product Number
2
Dosage Form
-
Strength
120MG
Approval Date
2016-06-23
Regulatory Status
RX
Drug Name
FENTANYL-100
Product Number
4
Dosage Form
-
Strength
100MCG/HR
Approval Date
2005-01-28
Active Ingredient
FENTANYL
Application Number
76258
Product Number
4
Dosage Form
-
Strength
100MCG/HR
Approval Date
2005-01-28
Regulatory Status
RX
Drug Name
FENTANYL-12
Product Number
5
Dosage Form
-
Strength
12.5MCG/HR
Approval Date
2007-01-23
Active Ingredient
FENTANYL
Application Number
76258
Product Number
5
Dosage Form
-
Strength
12.5MCG/HR
Approval Date
2007-01-23
Regulatory Status
RX
Drug Name
FENTANYL-25
Product Number
1
Dosage Form
-
Strength
25MCG/HR
Approval Date
2005-01-28
Active Ingredient
FENTANYL
Application Number
76258
Product Number
1
Dosage Form
-
Strength
25MCG/HR
Approval Date
2005-01-28
Regulatory Status
RX
Drug Name
FENTANYL-37
Product Number
6
Dosage Form
-
Strength
37.5MCG/HR
Approval Date
2014-12-29
Active Ingredient
FENTANYL
Application Number
76258
Product Number
6
Dosage Form
-
Strength
37.5MCG/HR
Approval Date
2014-12-29
Regulatory Status
RX
Drug Name
FENTANYL-50
Product Number
2
Dosage Form
-
Strength
50MCG/HR
Approval Date
2005-01-28
Active Ingredient
FENTANYL
Application Number
76258
Product Number
2
Dosage Form
-
Strength
50MCG/HR
Approval Date
2005-01-28
Regulatory Status
RX
Drug Name
FENTANYL-62
Product Number
7
Dosage Form
-
Strength
62.5MCG/HR
Approval Date
2014-12-29
Active Ingredient
FENTANYL
Application Number
76258
Product Number
7
Dosage Form
-
Strength
62.5MCG/HR
Approval Date
2014-12-29
Regulatory Status
RX
Drug Name
FENTANYL-75
Product Number
3
Dosage Form
-
Strength
75MCG/HR
Approval Date
2005-01-28
Active Ingredient
FENTANYL
Application Number
76258
Product Number
3
Dosage Form
-
Strength
75MCG/HR
Approval Date
2005-01-28
Regulatory Status
RX
Drug Name
FENTANYL-87
Product Number
8
Dosage Form
-
Strength
87.5MCG/HR
Approval Date
2014-12-29
Active Ingredient
FENTANYL
Application Number
76258
Product Number
8
Dosage Form
-
Strength
87.5MCG/HR
Approval Date
2014-12-29
Regulatory Status
RX
Drug Name
FERRIC CARBOXYMALTOSE
Product Number
1
Dosage Form
-
Strength
750MG IRON/15ML (50MG IRON/ML)
Approval Date
2026-06-25
Active Ingredient
FERRIC CARBOXYMALTOSE
Application Number
212572
Product Number
1
Dosage Form
-
Strength
750MG IRON/15ML (50MG IRON/ML)
Approval Date
2026-06-25
Regulatory Status
RX
Drug Name
FERRIC CARBOXYMALTOSE
Product Number
1
Dosage Form
-
Strength
1GM IRON/20ML (50MG IRON/ML)
Approval Date
2026-06-25
Active Ingredient
FERRIC CARBOXYMALTOSE
Application Number
217076
Product Number
1
Dosage Form
-
Strength
1GM IRON/20ML (50MG IRON/ML)
Approval Date
2026-06-25
Regulatory Status
RX
Drug Name
FERRIC CARBOXYMALTOSE
Product Number
1
Dosage Form
-
Strength
100MG IRON/2ML (50MG IRON/ML)
Approval Date
2026-06-25
Active Ingredient
FERRIC CARBOXYMALTOSE
Application Number
217769
Product Number
1
Dosage Form
-
Strength
100MG IRON/2ML (50MG IRON/ML)
Approval Date
2026-06-25
Regulatory Status
RX
Drug Name
FLUPHENAZINE DECANOATE
Product Number
1
Dosage Form
-
Strength
25MG/ML
Approval Date
2001-08-17
Active Ingredient
FLUPHENAZINE DECANOATE
Application Number
75918
Product Number
1
Dosage Form
-
Strength
25MG/ML
Approval Date
2001-08-17
Regulatory Status
RX
Drug Name
FLUVASTATIN SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2012-04-11
Active Ingredient
FLUVASTATIN SODIUM
Application Number
90595
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2012-04-11
Regulatory Status
RX
Drug Name
FLUVASTATIN SODIUM
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2012-04-11
Active Ingredient
FLUVASTATIN SODIUM
Application Number
90595
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2012-04-11
Regulatory Status
RX
Drug Name
FOMEPIZOLE
Product Number
1
Dosage Form
-
Strength
1.5GM/1.5ML (1GM/ML)
Approval Date
2008-03-03
Active Ingredient
FOMEPIZOLE
Application Number
78639
Product Number
1
Dosage Form
-
Strength
1.5GM/1.5ML (1GM/ML)
Approval Date
2008-03-03
Regulatory Status
RX
Drug Name
FOSAMPRENAVIR CALCIUM
Product Number
1
Dosage Form
-
Strength
EQ 700MG BASE
Approval Date
2016-04-15
Active Ingredient
FOSAMPRENAVIR CALCIUM
Application Number
204060
Product Number
1
Dosage Form
-
Strength
EQ 700MG BASE
Approval Date
2016-04-15
Regulatory Status
RX
Drug Name
FOSAPREPITANT DIMEGLUMINE
Product Number
2
Dosage Form
-
Strength
EQ 150MG BASE/VIAL
Approval Date
2019-09-05
Active Ingredient
FOSAPREPITANT DIMEGLUMINE
Application Number
204015
Product Number
2
Dosage Form
-
Strength
EQ 150MG BASE/VIAL
Approval Date
2019-09-05
Regulatory Status
RX
Drug Name
GEMCITABINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
200MG/5.26ML (38MG/ML)
Approval Date
2017-12-06
Active Ingredient
GEMCITABINE HYDROCHLORIDE
Application Number
205242
Product Number
1
Dosage Form
-
Strength
200MG/5.26ML (38MG/ML)
Approval Date
2017-12-06
Regulatory Status
RX
Drug Name
GEMCITABINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
1GM/26.3ML (38MG/ML)
Approval Date
2017-12-06
Active Ingredient
GEMCITABINE HYDROCHLORIDE
Application Number
205242
Product Number
2
Dosage Form
-
Strength
1GM/26.3ML (38MG/ML)
Approval Date
2017-12-06
Regulatory Status
RX
Drug Name
GEMCITABINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
2GM/52.6ML (38MG/ML)
Approval Date
2017-12-06
Active Ingredient
GEMCITABINE HYDROCHLORIDE
Application Number
205242
Product Number
3
Dosage Form
-
Strength
2GM/52.6ML (38MG/ML)
Approval Date
2017-12-06
Regulatory Status
RX
Drug Name
GEODON
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2001-02-05
Active Ingredient
ZIPRASIDONE HYDROCHLORIDE
Application Number
20825
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2001-02-05
Regulatory Status
RX
Drug Name
GEODON
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2001-02-05
Active Ingredient
ZIPRASIDONE HYDROCHLORIDE
Application Number
20825
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2001-02-05
Regulatory Status
RX
Drug Name
GEODON
Product Number
3
Dosage Form
-
Strength
EQ 60MG BASE
Approval Date
2001-02-05
Active Ingredient
ZIPRASIDONE HYDROCHLORIDE
Application Number
20825
Product Number
3
Dosage Form
-
Strength
EQ 60MG BASE
Approval Date
2001-02-05
Regulatory Status
RX
Drug Name
GEODON
Product Number
4
Dosage Form
-
Strength
EQ 80MG BASE
Approval Date
2001-02-05
Active Ingredient
ZIPRASIDONE HYDROCHLORIDE
Application Number
20825
Product Number
4
Dosage Form
-
Strength
EQ 80MG BASE
Approval Date
2001-02-05
Regulatory Status
RX
Drug Name
GEODON
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE/VIAL
Approval Date
2002-06-21
Active Ingredient
ZIPRASIDONE MESYLATE
Application Number
20919
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE/VIAL
Approval Date
2002-06-21
Regulatory Status
RX
Drug Name
GLATIRAMER ACETATE
Product Number
1
Dosage Form
-
Strength
20MG/ML
Approval Date
2017-10-03
Active Ingredient
GLATIRAMER ACETATE
Application Number
91646
Product Number
1
Dosage Form
-
Strength
20MG/ML
Approval Date
2017-10-03
Regulatory Status
RX
Drug Name
GLATIRAMER ACETATE
Product Number
1
Dosage Form
-
Strength
40MG/ML
Approval Date
2017-10-03
Active Ingredient
GLATIRAMER ACETATE
Application Number
206936
Product Number
1
Dosage Form
-
Strength
40MG/ML
Approval Date
2017-10-03
Regulatory Status
RX
Drug Name
GLUCAGON
Product Number
1
Dosage Form
-
Strength
1MG/VIAL
Approval Date
2024-12-12
Active Ingredient
GLUCAGON
Application Number
204468
Product Number
1
Dosage Form
-
Strength
1MG/VIAL
Approval Date
2024-12-12
Regulatory Status
RX
Drug Name
HALCINONIDE
Product Number
1
Dosage Form
-
Strength
0.1%
Approval Date
2019-08-12
Active Ingredient
HALCINONIDE
Application Number
211027
Product Number
1
Dosage Form
-
Strength
0.1%
Approval Date
2019-08-12
Regulatory Status
RX
Drug Name
HALOPERIDOL
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
1986-06-10
Active Ingredient
HALOPERIDOL
Application Number
70278
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
1986-06-10
Regulatory Status
RX
Drug Name
HALOPERIDOL
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2009-07-16
Active Ingredient
HALOPERIDOL
Application Number
70278
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2009-07-16
Regulatory Status
RX
Drug Name
HALOPERIDOL
Product Number
4
Dosage Form
-
Strength
1MG
Approval Date
1986-06-10
Active Ingredient
HALOPERIDOL
Application Number
70278
Product Number
4
Dosage Form
-
Strength
1MG
Approval Date
1986-06-10
Regulatory Status
RX
Drug Name
HALOPERIDOL
Product Number
5
Dosage Form
-
Strength
5MG
Approval Date
1986-06-10
Active Ingredient
HALOPERIDOL
Application Number
70278
Product Number
5
Dosage Form
-
Strength
5MG
Approval Date
1986-06-10
Regulatory Status
RX
Drug Name
HALOPERIDOL
Product Number
6
Dosage Form
-
Strength
0.5MG
Approval Date
1986-06-10
Active Ingredient
HALOPERIDOL
Application Number
70278
Product Number
6
Dosage Form
-
Strength
0.5MG
Approval Date
1986-06-10
Regulatory Status
RX
Drug Name
HALOPERIDOL
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/ML
Approval Date
2009-09-14
Active Ingredient
HALOPERIDOL LACTATE
Application Number
78347
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/ML
Approval Date
2009-09-14
Regulatory Status
RX
Drug Name
HALOPERIDOL DECANOATE
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/ML
Approval Date
2000-02-28
Active Ingredient
HALOPERIDOL DECANOATE
Application Number
75440
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/ML
Approval Date
2000-02-28
Regulatory Status
RX
Drug Name
HALOPERIDOL DECANOATE
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE/ML
Approval Date
2000-02-28
Active Ingredient
HALOPERIDOL DECANOATE
Application Number
75440
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE/ML
Approval Date
2000-02-28
Regulatory Status
RX
Drug Name
IMATINIB MESYLATE
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2017-06-21
Active Ingredient
IMATINIB MESYLATE
Application Number
204644
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2017-06-21
Regulatory Status
RX
Drug Name
IMATINIB MESYLATE
Product Number
2
Dosage Form
-
Strength
EQ 400MG BASE
Approval Date
2017-06-21
Active Ingredient
IMATINIB MESYLATE
Application Number
204644
Product Number
2
Dosage Form
-
Strength
EQ 400MG BASE
Approval Date
2017-06-21
Regulatory Status
RX
Drug Name
IRON SUCROSE
Product Number
1
Dosage Form
-
Strength
EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML)
Approval Date
2025-08-08
Active Ingredient
IRON SUCROSE
Application Number
212559
Product Number
1
Dosage Form
-
Strength
EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML)
Approval Date
2025-08-08
Regulatory Status
RX
Drug Name
IRON SUCROSE
Product Number
2
Dosage Form
-
Strength
EQ 100MG IRON/5ML (EQ 20MG IRON/ML)
Approval Date
2025-08-08
Active Ingredient
IRON SUCROSE
Application Number
212559
Product Number
2
Dosage Form
-
Strength
EQ 100MG IRON/5ML (EQ 20MG IRON/ML)
Approval Date
2025-08-08
Regulatory Status
RX
Drug Name
IRON SUCROSE
Product Number
3
Dosage Form
-
Strength
EQ 200MG IRON/10ML (EQ 20MG IRON/ML)
Approval Date
2025-08-08
Active Ingredient
IRON SUCROSE
Application Number
212559
Product Number
3
Dosage Form
-
Strength
EQ 200MG IRON/10ML (EQ 20MG IRON/ML)
Approval Date
2025-08-08
Regulatory Status
RX
Drug Name
ISOSULFAN BLUE
Product Number
1
Dosage Form
-
Strength
50MG/5ML (10MG/ML)
Approval Date
2010-07-20
Active Ingredient
ISOSULFAN BLUE
Application Number
90874
Product Number
1
Dosage Form
-
Strength
50MG/5ML (10MG/ML)
Approval Date
2010-07-20
Regulatory Status
RX
Drug Name
ISOSULFAN BLUE
Product Number
2
Dosage Form
-
Strength
10MG/ML (10MG/ML)
Approval Date
2026-01-28
Active Ingredient
ISOSULFAN BLUE
Application Number
90874
Product Number
2
Dosage Form
-
Strength
10MG/ML (10MG/ML)
Approval Date
2026-01-28
Regulatory Status
RX
Drug Name
ISOSULFAN BLUE
Product Number
3
Dosage Form
-
Strength
30MG/3ML (10MG/ML)
Approval Date
2026-01-28
Active Ingredient
ISOSULFAN BLUE
Application Number
90874
Product Number
3
Dosage Form
-
Strength
30MG/3ML (10MG/ML)
Approval Date
2026-01-28
Regulatory Status
RX
Drug Name
KETOPROFEN
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2002-02-20
Active Ingredient
KETOPROFEN
Application Number
75679
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2002-02-20
Regulatory Status
RX
Drug Name
KETOROLAC TROMETHAMINE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1997-05-16
Active Ingredient
KETOROLAC TROMETHAMINE
Application Number
74761
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1997-05-16
Regulatory Status
RX
Drug Name
LANSOPRAZOLE
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
2009-11-10
Active Ingredient
LANSOPRAZOLE
Application Number
90763
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
2009-11-10
Regulatory Status
RX
Drug Name
LANSOPRAZOLE
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
2009-11-10
Active Ingredient
LANSOPRAZOLE
Application Number
90763
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
2009-11-10
Regulatory Status
RX
Drug Name
LANSOPRAZOLE
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
2018-11-28
Active Ingredient
LANSOPRAZOLE
Application Number
202396
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
2018-11-28
Regulatory Status
RX
Drug Name
LANSOPRAZOLE
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
2018-11-28
Active Ingredient
LANSOPRAZOLE
Application Number
202396
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
2018-11-28
Regulatory Status
RX
Drug Name
LENALIDOMIDE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2022-08-30
Active Ingredient
LENALIDOMIDE
Application Number
213912
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2022-08-30
Regulatory Status
RX
Drug Name
LENALIDOMIDE
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2022-08-30
Active Ingredient
LENALIDOMIDE
Application Number
213912
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2022-08-30
Regulatory Status
RX
Drug Name
LENALIDOMIDE
Product Number
3
Dosage Form
-
Strength
15MG
Approval Date
2022-08-30
Active Ingredient
LENALIDOMIDE
Application Number
213912
Product Number
3
Dosage Form
-
Strength
15MG
Approval Date
2022-08-30
Regulatory Status
RX
Drug Name
LENALIDOMIDE
Product Number
4
Dosage Form
-
Strength
25MG
Approval Date
2022-08-30
Active Ingredient
LENALIDOMIDE
Application Number
213912
Product Number
4
Dosage Form
-
Strength
25MG
Approval Date
2022-08-30
Regulatory Status
RX
Drug Name
LENALIDOMIDE
Product Number
5
Dosage Form
-
Strength
2.5MG
Approval Date
2023-03-06
Active Ingredient
LENALIDOMIDE
Application Number
213912
Product Number
5
Dosage Form
-
Strength
2.5MG
Approval Date
2023-03-06
Regulatory Status
RX
Drug Name
LENALIDOMIDE
Product Number
6
Dosage Form
-
Strength
20MG
Approval Date
2023-03-06
Active Ingredient
LENALIDOMIDE
Application Number
213912
Product Number
6
Dosage Form
-
Strength
20MG
Approval Date
2023-03-06
Regulatory Status
RX
Drug Name
LEUCOVORIN CALCIUM PRESERVATIVE FREE
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE/VIAL
Approval Date
2017-05-19
Active Ingredient
LEUCOVORIN CALCIUM
Application Number
203800
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE/VIAL
Approval Date
2017-05-19
Regulatory Status
RX
Drug Name
LEUCOVORIN CALCIUM PRESERVATIVE FREE
Product Number
2
Dosage Form
-
Strength
EQ 200MG BASE/VIAL
Approval Date
2017-05-19
Active Ingredient
LEUCOVORIN CALCIUM
Application Number
203800
Product Number
2
Dosage Form
-
Strength
EQ 200MG BASE/VIAL
Approval Date
2017-05-19
Regulatory Status
RX
Drug Name
LEUCOVORIN CALCIUM PRESERVATIVE FREE
Product Number
3
Dosage Form
-
Strength
EQ 350MG BASE/VIAL
Approval Date
2017-05-19
Active Ingredient
LEUCOVORIN CALCIUM
Application Number
203800
Product Number
3
Dosage Form
-
Strength
EQ 350MG BASE/VIAL
Approval Date
2017-05-19
Regulatory Status
RX
Drug Name
LEVALBUTEROL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 0.25% BASE
Approval Date
2009-03-20
Active Ingredient
LEVALBUTEROL HYDROCHLORIDE
Application Number
78309
Product Number
1
Dosage Form
-
Strength
EQ 0.25% BASE
Approval Date
2009-03-20
Regulatory Status
RX
Drug Name
LEVETIRACETAM
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2008-11-04
Active Ingredient
LEVETIRACETAM
Application Number
76919
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2008-11-04
Regulatory Status
RX
Drug Name
LEVETIRACETAM
Product Number
3
Dosage Form
-
Strength
750MG
Approval Date
2008-11-04
Active Ingredient
LEVETIRACETAM
Application Number
76919
Product Number
3
Dosage Form
-
Strength
750MG
Approval Date
2008-11-04
Regulatory Status
RX
Drug Name
LEVETIRACETAM
Product Number
1
Dosage Form
-
Strength
1GM
Approval Date
2009-12-08
Active Ingredient
LEVETIRACETAM
Application Number
90261
Product Number
1
Dosage Form
-
Strength
1GM
Approval Date
2009-12-08
Regulatory Status
RX
Drug Name
LEVETIRACETAM
Product Number
1
Dosage Form
-
Strength
500MG/5ML (100MG/ML)
Approval Date
2016-09-16
Active Ingredient
LEVETIRACETAM
Application Number
203308
Product Number
1
Dosage Form
-
Strength
500MG/5ML (100MG/ML)
Approval Date
2016-09-16
Regulatory Status
RX
Drug Name
LEVETIRACETAM IN SODIUM CHLORIDE
Product Number
1
Dosage Form
-
Strength
500MG/100ML (5MG/ML)
Approval Date
2026-05-08
Active Ingredient
LEVETIRACETAM
Application Number
218364
Product Number
1
Dosage Form
-
Strength
500MG/100ML (5MG/ML)
Approval Date
2026-05-08
Regulatory Status
RX
Drug Name
LEVETIRACETAM IN SODIUM CHLORIDE
Product Number
2
Dosage Form
-
Strength
1GM/100ML (10MG/ML)
Approval Date
2026-05-08
Active Ingredient
LEVETIRACETAM
Application Number
218364
Product Number
2
Dosage Form
-
Strength
1GM/100ML (10MG/ML)
Approval Date
2026-05-08
Regulatory Status
RX
Drug Name
LEVETIRACETAM IN SODIUM CHLORIDE
Product Number
3
Dosage Form
-
Strength
1.5GM/100ML (15MG/ML)
Approval Date
2026-05-08
Active Ingredient
LEVETIRACETAM
Application Number
218364
Product Number
3
Dosage Form
-
Strength
1.5GM/100ML (15MG/ML)
Approval Date
2026-05-08
Regulatory Status
RX
Drug Name
LEVOTHYROXINE SODIUM
Product Number
1
Dosage Form
-
Strength
0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-06-05
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
76187
Product Number
1
Dosage Form
-
Strength
0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-06-05
Regulatory Status
RX
Drug Name
LEVOTHYROXINE SODIUM
Product Number
2
Dosage Form
-
Strength
0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-06-05
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
76187
Product Number
2
Dosage Form
-
Strength
0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-06-05
Regulatory Status
RX
Drug Name
LEVOTHYROXINE SODIUM
Product Number
3
Dosage Form
-
Strength
0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-06-05
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
76187
Product Number
3
Dosage Form
-
Strength
0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-06-05
Regulatory Status
RX
Drug Name
LEVOTHYROXINE SODIUM
Product Number
4
Dosage Form
-
Strength
0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-06-05
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
76187
Product Number
4
Dosage Form
-
Strength
0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-06-05
Regulatory Status
RX
Drug Name
LEVOTHYROXINE SODIUM
Product Number
5
Dosage Form
-
Strength
0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-06-05
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
76187
Product Number
5
Dosage Form
-
Strength
0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-06-05
Regulatory Status
RX
Drug Name
LEVOTHYROXINE SODIUM
Product Number
6
Dosage Form
-
Strength
0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-06-05
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
76187
Product Number
6
Dosage Form
-
Strength
0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-06-05
Regulatory Status
RX
Drug Name
LEVOTHYROXINE SODIUM
Product Number
7
Dosage Form
-
Strength
0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-06-05
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
76187
Product Number
7
Dosage Form
-
Strength
0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-06-05
Regulatory Status
RX
Drug Name
LEVOTHYROXINE SODIUM
Product Number
8
Dosage Form
-
Strength
0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-06-05
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
76187
Product Number
8
Dosage Form
-
Strength
0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-06-05
Regulatory Status
RX
Drug Name
LEVOTHYROXINE SODIUM
Product Number
9
Dosage Form
-
Strength
0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-06-05
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
76187
Product Number
9
Dosage Form
-
Strength
0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-06-05
Regulatory Status
RX
Drug Name
LEVOTHYROXINE SODIUM
Product Number
10
Dosage Form
-
Strength
0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-06-05
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
76187
Product Number
10
Dosage Form
-
Strength
0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-06-05
Regulatory Status
RX
Drug Name
LEVOTHYROXINE SODIUM
Product Number
11
Dosage Form
-
Strength
0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-06-05
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
76187
Product Number
11
Dosage Form
-
Strength
0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-06-05
Regulatory Status
RX
Drug Name
LEVOTHYROXINE SODIUM
Product Number
12
Dosage Form
-
Strength
0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2006-12-13
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
76187
Product Number
12
Dosage Form
-
Strength
0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2006-12-13
Regulatory Status
RX
Drug Name
LINAGLIPTIN
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2025-11-03
Active Ingredient
LINAGLIPTIN
Application Number
208431
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2025-11-03
Regulatory Status
RX
Drug Name
LIRAGLUTIDE
Product Number
1
Dosage Form
-
Strength
18MG/3ML (6MG/ML)
Approval Date
2026-06-15
Active Ingredient
LIRAGLUTIDE
Application Number
213155
Product Number
1
Dosage Form
-
Strength
18MG/3ML (6MG/ML)
Approval Date
2026-06-15
Regulatory Status
RX
Drug Name
LISDEXAMFETAMINE DIMESYLATE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2023-08-25
Active Ingredient
LISDEXAMFETAMINE DIMESYLATE
Application Number
202835
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2023-08-25
Regulatory Status
RX
Drug Name
LISDEXAMFETAMINE DIMESYLATE
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2023-08-25
Active Ingredient
LISDEXAMFETAMINE DIMESYLATE
Application Number
202835
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2023-08-25
Regulatory Status
RX
Drug Name
LISDEXAMFETAMINE DIMESYLATE
Product Number
3
Dosage Form
-
Strength
30MG
Approval Date
2023-08-25
Active Ingredient
LISDEXAMFETAMINE DIMESYLATE
Application Number
202835
Product Number
3
Dosage Form
-
Strength
30MG
Approval Date
2023-08-25
Regulatory Status
RX
Drug Name
LISDEXAMFETAMINE DIMESYLATE
Product Number
4
Dosage Form
-
Strength
40MG
Approval Date
2023-08-25
Active Ingredient
LISDEXAMFETAMINE DIMESYLATE
Application Number
202835
Product Number
4
Dosage Form
-
Strength
40MG
Approval Date
2023-08-25
Regulatory Status
RX
Drug Name
LISDEXAMFETAMINE DIMESYLATE
Product Number
5
Dosage Form
-
Strength
50MG
Approval Date
2023-08-25
Active Ingredient
LISDEXAMFETAMINE DIMESYLATE
Application Number
202835
Product Number
5
Dosage Form
-
Strength
50MG
Approval Date
2023-08-25
Regulatory Status
RX
Drug Name
LISDEXAMFETAMINE DIMESYLATE
Product Number
6
Dosage Form
-
Strength
60MG
Approval Date
2023-08-25
Active Ingredient
LISDEXAMFETAMINE DIMESYLATE
Application Number
202835
Product Number
6
Dosage Form
-
Strength
60MG
Approval Date
2023-08-25
Regulatory Status
RX
Drug Name
LISDEXAMFETAMINE DIMESYLATE
Product Number
7
Dosage Form
-
Strength
70MG
Approval Date
2023-08-25
Active Ingredient
LISDEXAMFETAMINE DIMESYLATE
Application Number
202835
Product Number
7
Dosage Form
-
Strength
70MG
Approval Date
2023-08-25
Regulatory Status
RX
Drug Name
LOPERAMIDE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
1991-09-18
Active Ingredient
LOPERAMIDE HYDROCHLORIDE
Application Number
72741
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
1991-09-18
Regulatory Status
RX
Drug Name
LOPINAVIR AND RITONAVIR
Product Number
1
Dosage Form
-
Strength
100MG;25MG
Approval Date
2024-02-07
Active Ingredient
LOPINAVIR; RITONAVIR
Application Number
79074
Product Number
1
Dosage Form
-
Strength
100MG;25MG
Approval Date
2024-02-07
Regulatory Status
RX
Drug Name
LOPINAVIR AND RITONAVIR
Product Number
2
Dosage Form
-
Strength
200MG;50MG
Approval Date
2024-02-07
Active Ingredient
LOPINAVIR; RITONAVIR
Application Number
79074
Product Number
2
Dosage Form
-
Strength
200MG;50MG
Approval Date
2024-02-07
Regulatory Status
RX
Drug Name
MACITENTAN
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2025-12-03
Active Ingredient
MACITENTAN
Application Number
211161
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2025-12-03
Regulatory Status
RX
Drug Name
MECLOFENAMATE SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
1986-09-03
Active Ingredient
MECLOFENAMATE SODIUM
Application Number
71081
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
1986-09-03
Regulatory Status
RX
Drug Name
MECLOFENAMATE SODIUM
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
1986-09-03
Active Ingredient
MECLOFENAMATE SODIUM
Application Number
71081
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
1986-09-03
Regulatory Status
RX
Drug Name
MELPHALAN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/VIAL
Approval Date
2009-06-09
Active Ingredient
MELPHALAN HYDROCHLORIDE
Application Number
90270
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/VIAL
Approval Date
2009-06-09
Regulatory Status
RX
Drug Name
MESALAMINE
Product Number
1
Dosage Form
-
Strength
375MG
Approval Date
2019-11-20
Active Ingredient
MESALAMINE
Application Number
207271
Product Number
1
Dosage Form
-
Strength
375MG
Approval Date
2019-11-20
Regulatory Status
RX
Drug Name
METFORMIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2002-01-25
Active Ingredient
METFORMIN HYDROCHLORIDE
Application Number
75973
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2002-01-25
Regulatory Status
RX
Drug Name
METFORMIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
850MG
Approval Date
2002-01-25
Active Ingredient
METFORMIN HYDROCHLORIDE
Application Number
75973
Product Number
2
Dosage Form
-
Strength
850MG
Approval Date
2002-01-25
Regulatory Status
RX
Drug Name
METFORMIN HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
1GM
Approval Date
2002-01-25
Active Ingredient
METFORMIN HYDROCHLORIDE
Application Number
75973
Product Number
3
Dosage Form
-
Strength
1GM
Approval Date
2002-01-25
Regulatory Status
RX
Drug Name
METFORMIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2012-08-01
Active Ingredient
METFORMIN HYDROCHLORIDE
Application Number
200690
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2012-08-01
Regulatory Status
RX
Drug Name
METFORMIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
1GM
Approval Date
2012-08-01
Active Ingredient
METFORMIN HYDROCHLORIDE
Application Number
200690
Product Number
2
Dosage Form
-
Strength
1GM
Approval Date
2012-08-01
Regulatory Status
RX
Drug Name
METHADONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
1982-01-01
Active Ingredient
METHADONE HYDROCHLORIDE
Application Number
21624
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
METHIMAZOLE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2000-03-29
Active Ingredient
METHIMAZOLE
Application Number
40350
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2000-03-29
Regulatory Status
RX
Drug Name
METHIMAZOLE
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2000-03-29
Active Ingredient
METHIMAZOLE
Application Number
40350
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2000-03-29
Regulatory Status
RX
Drug Name
METHOTREXATE SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE
Approval Date
1992-05-15
Active Ingredient
METHOTREXATE SODIUM
Application Number
81235
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE
Approval Date
1992-05-15
Regulatory Status
RX
Drug Name
METOLAZONE
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2003-12-23
Active Ingredient
METOLAZONE
Application Number
76698
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2003-12-23
Regulatory Status
RX
Drug Name
METOLAZONE
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2004-10-19
Active Ingredient
METOLAZONE
Application Number
76698
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2004-10-19
Regulatory Status
RX
Drug Name
METOLAZONE
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2004-10-19
Active Ingredient
METOLAZONE
Application Number
76698
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2004-10-19
Regulatory Status
RX
Drug Name
METOPROLOL TARTRATE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2004-01-16
Active Ingredient
METOPROLOL TARTRATE
Application Number
76704
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2004-01-16
Regulatory Status
RX
Drug Name
METOPROLOL TARTRATE
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2004-01-16
Active Ingredient
METOPROLOL TARTRATE
Application Number
76704
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2004-01-16
Regulatory Status
RX
Drug Name
METOPROLOL TARTRATE
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2004-01-16
Active Ingredient
METOPROLOL TARTRATE
Application Number
76704
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2004-01-16
Regulatory Status
RX
Drug Name
METOPROLOL TARTRATE
Product Number
4
Dosage Form
-
Strength
37.5MG
Approval Date
2015-03-18
Active Ingredient
METOPROLOL TARTRATE
Application Number
76704
Product Number
4
Dosage Form
-
Strength
37.5MG
Approval Date
2015-03-18
Regulatory Status
RX
Drug Name
METOPROLOL TARTRATE
Product Number
5
Dosage Form
-
Strength
75MG
Approval Date
2015-03-18
Active Ingredient
METOPROLOL TARTRATE
Application Number
76704
Product Number
5
Dosage Form
-
Strength
75MG
Approval Date
2015-03-18
Regulatory Status
RX
Drug Name
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
25MG;50MG
Approval Date
2004-08-20
Active Ingredient
HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE
Application Number
76792
Product Number
1
Dosage Form
-
Strength
25MG;50MG
Approval Date
2004-08-20
Regulatory Status
RX
Drug Name
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE
Product Number
2
Dosage Form
-
Strength
25MG;100MG
Approval Date
2004-08-20
Active Ingredient
HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE
Application Number
76792
Product Number
2
Dosage Form
-
Strength
25MG;100MG
Approval Date
2004-08-20
Regulatory Status
RX
Drug Name
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE
Product Number
3
Dosage Form
-
Strength
50MG;100MG
Approval Date
2004-08-20
Active Ingredient
HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE
Application Number
76792
Product Number
3
Dosage Form
-
Strength
50MG;100MG
Approval Date
2004-08-20
Regulatory Status
RX
Drug Name
MIDODRINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2003-09-10
Active Ingredient
MIDODRINE HYDROCHLORIDE
Application Number
76577
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2003-09-10
Regulatory Status
RX
Drug Name
MIDODRINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2003-09-10
Active Ingredient
MIDODRINE HYDROCHLORIDE
Application Number
76577
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2003-09-10
Regulatory Status
RX
Drug Name
MIDODRINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2003-09-10
Active Ingredient
MIDODRINE HYDROCHLORIDE
Application Number
76577
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2003-09-10
Regulatory Status
RX
Drug Name
MIRTAZAPINE
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
2003-06-19
Active Ingredient
MIRTAZAPINE
Application Number
76122
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
2003-06-19
Regulatory Status
RX
Drug Name
MIRTAZAPINE
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
2003-06-19
Active Ingredient
MIRTAZAPINE
Application Number
76122
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
2003-06-19
Regulatory Status
RX
Drug Name
MIRTAZAPINE
Product Number
3
Dosage Form
-
Strength
45MG
Approval Date
2003-06-19
Active Ingredient
MIRTAZAPINE
Application Number
76122
Product Number
3
Dosage Form
-
Strength
45MG
Approval Date
2003-06-19
Regulatory Status
RX
Drug Name
MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
Product Number
1
Dosage Form
-
Strength
400MG/250ML (1.6MG/ML)
Approval Date
2017-05-05
Active Ingredient
MOXIFLOXACIN HYDROCHLORIDE
Application Number
205833
Product Number
1
Dosage Form
-
Strength
400MG/250ML (1.6MG/ML)
Approval Date
2017-05-05
Regulatory Status
RX
Drug Name
MYCOPHENOLATE MOFETIL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
500MG/VIAL
Approval Date
2017-03-31
Active Ingredient
MYCOPHENOLATE MOFETIL HYDROCHLORIDE
Application Number
203859
Product Number
1
Dosage Form
-
Strength
500MG/VIAL
Approval Date
2017-03-31
Regulatory Status
RX
Drug Name
NALOXONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
0.4MG/ML
Approval Date
2014-03-06
Active Ingredient
NALOXONE HYDROCHLORIDE
Application Number
204997
Product Number
1
Dosage Form
-
Strength
0.4MG/ML
Approval Date
2014-03-06
Regulatory Status
RX
Drug Name
NALOXONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
0.4MG/ML
Approval Date
2016-06-29
Active Ingredient
NALOXONE HYDROCHLORIDE
Application Number
205014
Product Number
1
Dosage Form
-
Strength
0.4MG/ML
Approval Date
2016-06-29
Regulatory Status
RX
Drug Name
NALOXONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2022-06-09
Active Ingredient
NALOXONE HYDROCHLORIDE
Application Number
213843
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2022-06-09
Regulatory Status
RX
Drug Name
NEURONTIN
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
1993-12-30
Active Ingredient
GABAPENTIN
Application Number
20235
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
1993-12-30
Regulatory Status
RX
Drug Name
NEURONTIN
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
1993-12-30
Active Ingredient
GABAPENTIN
Application Number
20235
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
1993-12-30
Regulatory Status
RX
Drug Name
NEURONTIN
Product Number
3
Dosage Form
-
Strength
400MG
Approval Date
1993-12-30
Active Ingredient
GABAPENTIN
Application Number
20235
Product Number
3
Dosage Form
-
Strength
400MG
Approval Date
1993-12-30
Regulatory Status
RX
Drug Name
NEURONTIN
Product Number
1
Dosage Form
-
Strength
600MG
Approval Date
1998-10-09
Active Ingredient
GABAPENTIN
Application Number
20882
Product Number
1
Dosage Form
-
Strength
600MG
Approval Date
1998-10-09
Regulatory Status
RX
Drug Name
NEURONTIN
Product Number
2
Dosage Form
-
Strength
800MG
Approval Date
1998-10-09
Active Ingredient
GABAPENTIN
Application Number
20882
Product Number
2
Dosage Form
-
Strength
800MG
Approval Date
1998-10-09
Regulatory Status
RX
Drug Name
NEURONTIN
Product Number
1
Dosage Form
-
Strength
250MG/5ML
Approval Date
2000-03-02
Active Ingredient
GABAPENTIN
Application Number
21129
Product Number
1
Dosage Form
-
Strength
250MG/5ML
Approval Date
2000-03-02
Regulatory Status
RX
Drug Name
NEVIRAPINE
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2012-05-22
Active Ingredient
NEVIRAPINE
Application Number
202523
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2012-05-22
Regulatory Status
RX
Drug Name
NEVIRAPINE
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
2014-10-27
Active Ingredient
NEVIRAPINE
Application Number
205651
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
2014-10-27
Regulatory Status
RX
Drug Name
NITROGLYCERIN
Product Number
1
Dosage Form
-
Strength
0.6MG/HR
Approval Date
1996-08-30
Active Ingredient
NITROGLYCERIN
Application Number
74559
Product Number
1
Dosage Form
-
Strength
0.6MG/HR
Approval Date
1996-08-30
Regulatory Status
RX
Drug Name
NITROGLYCERIN
Product Number
2
Dosage Form
-
Strength
0.4MG/HR
Approval Date
1996-08-30
Active Ingredient
NITROGLYCERIN
Application Number
74559
Product Number
2
Dosage Form
-
Strength
0.4MG/HR
Approval Date
1996-08-30
Regulatory Status
RX
Drug Name
NITROGLYCERIN
Product Number
3
Dosage Form
-
Strength
0.2MG/HR
Approval Date
1996-08-30
Active Ingredient
NITROGLYCERIN
Application Number
74559
Product Number
3
Dosage Form
-
Strength
0.2MG/HR
Approval Date
1996-08-30
Regulatory Status
RX
Drug Name
NITROGLYCERIN
Product Number
4
Dosage Form
-
Strength
0.1MG/HR
Approval Date
1998-02-06
Active Ingredient
NITROGLYCERIN
Application Number
74559
Product Number
4
Dosage Form
-
Strength
0.1MG/HR
Approval Date
1998-02-06
Regulatory Status
RX
Drug Name
NITROSTAT
Product Number
1
Dosage Form
-
Strength
0.3MG
Approval Date
2000-05-01
Active Ingredient
NITROGLYCERIN
Application Number
21134
Product Number
1
Dosage Form
-
Strength
0.3MG
Approval Date
2000-05-01
Regulatory Status
RX
Drug Name
NITROSTAT
Product Number
2
Dosage Form
-
Strength
0.4MG
Approval Date
2000-05-01
Active Ingredient
NITROGLYCERIN
Application Number
21134
Product Number
2
Dosage Form
-
Strength
0.4MG
Approval Date
2000-05-01
Regulatory Status
RX
Drug Name
NITROSTAT
Product Number
3
Dosage Form
-
Strength
0.6MG
Approval Date
2000-05-01
Active Ingredient
NITROGLYCERIN
Application Number
21134
Product Number
3
Dosage Form
-
Strength
0.6MG
Approval Date
2000-05-01
Regulatory Status
RX
Drug Name
NOREPINEPHRINE BITARTRATE
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/ML
Approval Date
2018-10-04
Active Ingredient
NOREPINEPHRINE BITARTRATE
Application Number
211242
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/ML
Approval Date
2018-10-04
Regulatory Status
RX
Drug Name
NORVASC
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE
Approval Date
1992-07-31
Active Ingredient
AMLODIPINE BESYLATE
Application Number
19787
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE
Approval Date
1992-07-31
Regulatory Status
RX
Drug Name
NORVASC
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
1992-07-31
Active Ingredient
AMLODIPINE BESYLATE
Application Number
19787
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
1992-07-31
Regulatory Status
RX
Drug Name
NORVASC
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
1992-07-31
Active Ingredient
AMLODIPINE BESYLATE
Application Number
19787
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
1992-07-31
Regulatory Status
RX
Drug Name
OCTREOTIDE ACETATE
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/VIAL
Approval Date
2025-12-12
Active Ingredient
OCTREOTIDE ACETATE
Application Number
216589
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/VIAL
Approval Date
2025-12-12
Regulatory Status
RX
Drug Name
OCTREOTIDE ACETATE
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE/VIAL
Approval Date
2025-12-12
Active Ingredient
OCTREOTIDE ACETATE
Application Number
216589
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE/VIAL
Approval Date
2025-12-12
Regulatory Status
RX
Drug Name
OCTREOTIDE ACETATE
Product Number
3
Dosage Form
-
Strength
EQ 30MG BASE/VIAL
Approval Date
2025-12-12
Active Ingredient
OCTREOTIDE ACETATE
Application Number
216589
Product Number
3
Dosage Form
-
Strength
EQ 30MG BASE/VIAL
Approval Date
2025-12-12
Regulatory Status
RX
Drug Name
OCTREOTIDE ACETATE (PRESERVATIVE FREE)
Product Number
1
Dosage Form
-
Strength
EQ 0.05MG BASE/ML
Approval Date
2011-02-10
Active Ingredient
OCTREOTIDE ACETATE
Application Number
79198
Product Number
1
Dosage Form
-
Strength
EQ 0.05MG BASE/ML
Approval Date
2011-02-10
Regulatory Status
RX
Drug Name
OCTREOTIDE ACETATE (PRESERVATIVE FREE)
Product Number
2
Dosage Form
-
Strength
EQ 0.1MG BASE/ML
Approval Date
2011-02-10
Active Ingredient
OCTREOTIDE ACETATE
Application Number
79198
Product Number
2
Dosage Form
-
Strength
EQ 0.1MG BASE/ML
Approval Date
2011-02-10
Regulatory Status
RX
Drug Name
OCTREOTIDE ACETATE (PRESERVATIVE FREE)
Product Number
3
Dosage Form
-
Strength
EQ 0.5MG BASE/ML
Approval Date
2011-02-10
Active Ingredient
OCTREOTIDE ACETATE
Application Number
79198
Product Number
3
Dosage Form
-
Strength
EQ 0.5MG BASE/ML
Approval Date
2011-02-10
Regulatory Status
RX
Drug Name
OXALIPLATIN
Product Number
1
Dosage Form
-
Strength
50MG/10ML (5MG/ML)
Approval Date
2012-08-07
Active Ingredient
OXALIPLATIN
Application Number
91358
Product Number
1
Dosage Form
-
Strength
50MG/10ML (5MG/ML)
Approval Date
2012-08-07
Regulatory Status
RX
Drug Name
OXALIPLATIN
Product Number
2
Dosage Form
-
Strength
100MG/20ML (5MG/ML)
Approval Date
2012-08-07
Active Ingredient
OXALIPLATIN
Application Number
91358
Product Number
2
Dosage Form
-
Strength
100MG/20ML (5MG/ML)
Approval Date
2012-08-07
Regulatory Status
RX
Drug Name
PACLITAXEL
Product Number
1
Dosage Form
-
Strength
100MG/VIAL
Approval Date
2025-08-19
Active Ingredient
PACLITAXEL
Application Number
217877
Product Number
1
Dosage Form
-
Strength
100MG/VIAL
Approval Date
2025-08-19
Regulatory Status
RX
Drug Name
PALONOSETRON HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)
Approval Date
2018-09-19
Active Ingredient
PALONOSETRON HYDROCHLORIDE
Application Number
206416
Product Number
1
Dosage Form
-
Strength
EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)
Approval Date
2018-09-19
Regulatory Status
RX
Drug Name
PAMIDRONATE DISODIUM
Product Number
1
Dosage Form
-
Strength
30MG/10ML (3MG/ML)
Approval Date
2008-10-31
Active Ingredient
PAMIDRONATE DISODIUM
Application Number
78520
Product Number
1
Dosage Form
-
Strength
30MG/10ML (3MG/ML)
Approval Date
2008-10-31
Regulatory Status
RX
Drug Name
PAMIDRONATE DISODIUM
Product Number
2
Dosage Form
-
Strength
90MG/10ML (9MG/ML)
Approval Date
2008-10-31
Active Ingredient
PAMIDRONATE DISODIUM
Application Number
78520
Product Number
2
Dosage Form
-
Strength
90MG/10ML (9MG/ML)
Approval Date
2008-10-31
Regulatory Status
RX
Drug Name
PANTOPRAZOLE SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2011-01-19
Active Ingredient
PANTOPRAZOLE SODIUM
Application Number
90970
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2011-01-19
Regulatory Status
RX
Drug Name
PANTOPRAZOLE SODIUM
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2011-01-19
Active Ingredient
PANTOPRAZOLE SODIUM
Application Number
90970
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2011-01-19
Regulatory Status
RX
Drug Name
PAROXETINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2008-03-13
Active Ingredient
PAROXETINE HYDROCHLORIDE
Application Number
78902
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2008-03-13
Regulatory Status
RX
Drug Name
PAROXETINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2008-03-13
Active Ingredient
PAROXETINE HYDROCHLORIDE
Application Number
78902
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2008-03-13
Regulatory Status
RX
Drug Name
PAROXETINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 30MG BASE
Approval Date
2008-03-13
Active Ingredient
PAROXETINE HYDROCHLORIDE
Application Number
78902
Product Number
3
Dosage Form
-
Strength
EQ 30MG BASE
Approval Date
2008-03-13
Regulatory Status
RX
Drug Name
PAROXETINE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2008-03-13
Active Ingredient
PAROXETINE HYDROCHLORIDE
Application Number
78902
Product Number
4
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2008-03-13
Regulatory Status
RX
Drug Name
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
50MG;4MG
Approval Date
1988-11-10
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
Application Number
71443
Product Number
1
Dosage Form
-
Strength
50MG;4MG
Approval Date
1988-11-10
Regulatory Status
RX
Drug Name
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
10MG;2MG
Approval Date
1988-11-10
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
Application Number
71443
Product Number
2
Dosage Form
-
Strength
10MG;2MG
Approval Date
1988-11-10
Regulatory Status
RX
Drug Name
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
10MG;4MG
Approval Date
1988-11-10
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
Application Number
71443
Product Number
3
Dosage Form
-
Strength
10MG;4MG
Approval Date
1988-11-10
Regulatory Status
RX
Drug Name
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
25MG;2MG
Approval Date
1988-11-10
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
Application Number
71443
Product Number
4
Dosage Form
-
Strength
25MG;2MG
Approval Date
1988-11-10
Regulatory Status
RX
Drug Name
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
Product Number
5
Dosage Form
-
Strength
25MG;4MG
Approval Date
1988-11-10
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
Application Number
71443
Product Number
5
Dosage Form
-
Strength
25MG;4MG
Approval Date
1988-11-10
Regulatory Status
RX
Drug Name
PHENYTEK
Product Number
2
Dosage Form
-
Strength
200MG EXTENDED
Approval Date
2001-12-06
Active Ingredient
PHENYTOIN SODIUM
Application Number
40298
Product Number
2
Dosage Form
-
Strength
200MG EXTENDED
Approval Date
2001-12-06
Regulatory Status
RX
Drug Name
PHENYTEK
Product Number
3
Dosage Form
-
Strength
300MG EXTENDED
Approval Date
2001-12-06
Active Ingredient
PHENYTOIN SODIUM
Application Number
40298
Product Number
3
Dosage Form
-
Strength
300MG EXTENDED
Approval Date
2001-12-06
Regulatory Status
RX
Drug Name
PITAVASTATIN CALCIUM
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2019-04-04
Active Ingredient
PITAVASTATIN CALCIUM
Application Number
206070
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2019-04-04
Regulatory Status
RX
Drug Name
PITAVASTATIN CALCIUM
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2019-04-04
Active Ingredient
PITAVASTATIN CALCIUM
Application Number
206070
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2019-04-04
Regulatory Status
RX
Drug Name
PITAVASTATIN CALCIUM
Product Number
3
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2019-04-04
Active Ingredient
PITAVASTATIN CALCIUM
Application Number
206070
Product Number
3
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2019-04-04
Regulatory Status
RX
Drug Name
POSACONAZOLE
Product Number
1
Dosage Form
-
Strength
300MG/16.7ML (18MG/ML)
Approval Date
2023-12-26
Active Ingredient
POSACONAZOLE
Application Number
211500
Product Number
1
Dosage Form
-
Strength
300MG/16.7ML (18MG/ML)
Approval Date
2023-12-26
Regulatory Status
RX
Drug Name
PRASUGREL
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2017-07-12
Active Ingredient
PRASUGREL HYDROCHLORIDE
Application Number
205927
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2017-07-12
Regulatory Status
RX
Drug Name
PRASUGREL
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2017-07-12
Active Ingredient
PRASUGREL HYDROCHLORIDE
Application Number
205927
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2017-07-12
Regulatory Status
RX
Drug Name
PRAZOSIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
1989-05-16
Active Ingredient
PRAZOSIN HYDROCHLORIDE
Application Number
72575
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
1989-05-16
Regulatory Status
RX
Drug Name
PRAZOSIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
1989-05-16
Active Ingredient
PRAZOSIN HYDROCHLORIDE
Application Number
72575
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
1989-05-16
Regulatory Status
RX
Drug Name
PRAZOSIN HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
1989-05-16
Active Ingredient
PRAZOSIN HYDROCHLORIDE
Application Number
72575
Product Number
3
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
1989-05-16
Regulatory Status
RX
Drug Name
PREDNISONE
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
1982-01-01
Active Ingredient
PREDNISONE
Application Number
83677
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
PREDNISONE
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
1982-01-01
Active Ingredient
PREDNISONE
Application Number
83677
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
PREDNISONE
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
1985-12-04
Active Ingredient
PREDNISONE
Application Number
83677
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
1985-12-04
Regulatory Status
RX
Drug Name
PROCHLORPERAZINE EDISYLATE
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/ML
Approval Date
2018-10-25
Active Ingredient
PROCHLORPERAZINE EDISYLATE
Application Number
210710
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/ML
Approval Date
2018-10-25
Regulatory Status
RX
Drug Name
PROCTOFOAM HC
Product Number
1
Dosage Form
-
Strength
1%;1%
Approval Date
1982-01-01
Active Ingredient
HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE
Application Number
86195
Product Number
1
Dosage Form
-
Strength
1%;1%
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
PROPRANOLOL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
1985-11-19
Active Ingredient
PROPRANOLOL HYDROCHLORIDE
Application Number
70213
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
1985-11-19
Regulatory Status
RX
Drug Name
PROPRANOLOL HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
1985-11-19
Active Ingredient
PROPRANOLOL HYDROCHLORIDE
Application Number
70213
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
1985-11-19
Regulatory Status
RX
Drug Name
PROPRANOLOL HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
20MG
Approval Date
1985-11-19
Active Ingredient
PROPRANOLOL HYDROCHLORIDE
Application Number
70213
Product Number
3
Dosage Form
-
Strength
20MG
Approval Date
1985-11-19
Regulatory Status
RX
Drug Name
PROPRANOLOL HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
80MG
Approval Date
1985-11-19
Active Ingredient
PROPRANOLOL HYDROCHLORIDE
Application Number
70213
Product Number
4
Dosage Form
-
Strength
80MG
Approval Date
1985-11-19
Regulatory Status
RX
Drug Name
PROPRANOLOL HYDROCHLORIDE
Product Number
5
Dosage Form
-
Strength
60MG
Approval Date
2011-04-08
Active Ingredient
PROPRANOLOL HYDROCHLORIDE
Application Number
70213
Product Number
5
Dosage Form
-
Strength
60MG
Approval Date
2011-04-08
Regulatory Status
RX
Drug Name
REVATIO
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2005-06-03
Active Ingredient
SILDENAFIL CITRATE
Application Number
21845
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2005-06-03
Regulatory Status
RX
Drug Name
REVATIO
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)
Approval Date
2009-11-18
Active Ingredient
SILDENAFIL CITRATE
Application Number
22473
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)
Approval Date
2009-11-18
Regulatory Status
RX
Drug Name
RIFAMPIN
Product Number
1
Dosage Form
-
Strength
600MG/VIAL
Approval Date
2008-05-22
Active Ingredient
RIFAMPIN
Application Number
65421
Product Number
1
Dosage Form
-
Strength
600MG/VIAL
Approval Date
2008-05-22
Regulatory Status
RX
Drug Name
RIMSO-50
Product Number
1
Dosage Form
-
Strength
50%
Approval Date
1982-01-01
Active Ingredient
DIMETHYL SULFOXIDE
Application Number
17788
Product Number
1
Dosage Form
-
Strength
50%
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
RIVASTIGMINE
Product Number
1
Dosage Form
-
Strength
4.6MG/24HR
Approval Date
2018-06-20
Active Ingredient
RIVASTIGMINE
Application Number
205622
Product Number
1
Dosage Form
-
Strength
4.6MG/24HR
Approval Date
2018-06-20
Regulatory Status
RX
Drug Name
RIVASTIGMINE
Product Number
2
Dosage Form
-
Strength
9.5MG/24HR
Approval Date
2018-06-20
Active Ingredient
RIVASTIGMINE
Application Number
205622
Product Number
2
Dosage Form
-
Strength
9.5MG/24HR
Approval Date
2018-06-20
Regulatory Status
RX
Drug Name
RIVASTIGMINE
Product Number
3
Dosage Form
-
Strength
13.3MG/24HR
Approval Date
2018-06-20
Active Ingredient
RIVASTIGMINE
Application Number
205622
Product Number
3
Dosage Form
-
Strength
13.3MG/24HR
Approval Date
2018-06-20
Regulatory Status
RX
Drug Name
ROCURONIUM BROMIDE
Product Number
1
Dosage Form
-
Strength
50MG/5ML (10MG/ML)
Approval Date
2008-11-26
Active Ingredient
ROCURONIUM BROMIDE
Application Number
79199
Product Number
1
Dosage Form
-
Strength
50MG/5ML (10MG/ML)
Approval Date
2008-11-26
Regulatory Status
RX
Drug Name
ROCURONIUM BROMIDE
Product Number
2
Dosage Form
-
Strength
100MG/10ML (10MG/ML)
Approval Date
2008-11-26
Active Ingredient
ROCURONIUM BROMIDE
Application Number
79199
Product Number
2
Dosage Form
-
Strength
100MG/10ML (10MG/ML)
Approval Date
2008-11-26
Regulatory Status
RX
Drug Name
ROPIVACAINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
200MG/100ML (2MG/ML)
Approval Date
2023-10-26
Active Ingredient
ROPIVACAINE HYDROCHLORIDE
Application Number
206091
Product Number
1
Dosage Form
-
Strength
200MG/100ML (2MG/ML)
Approval Date
2023-10-26
Regulatory Status
RX
Drug Name
ROPIVACAINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
400MG/200ML (2MG/ML)
Approval Date
2023-10-26
Active Ingredient
ROPIVACAINE HYDROCHLORIDE
Application Number
206091
Product Number
2
Dosage Form
-
Strength
400MG/200ML (2MG/ML)
Approval Date
2023-10-26
Regulatory Status
RX
Drug Name
ROWASA
Product Number
1
Dosage Form
-
Strength
4GM/60ML
Approval Date
1987-12-24
Active Ingredient
MESALAMINE
Application Number
19618
Product Number
1
Dosage Form
-
Strength
4GM/60ML
Approval Date
1987-12-24
Regulatory Status
RX
Drug Name
SAXAGLIPTIN
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE
Approval Date
2023-07-31
Active Ingredient
SAXAGLIPTIN HYDROCHLORIDE
Application Number
205980
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE
Approval Date
2023-07-31
Regulatory Status
RX
Drug Name
SAXAGLIPTIN
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2023-07-31
Active Ingredient
SAXAGLIPTIN HYDROCHLORIDE
Application Number
205980
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2023-07-31
Regulatory Status
RX
Drug Name
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
500MG;EQ 5MG BASE
Approval Date
2023-07-31
Active Ingredient
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
Application Number
205981
Product Number
1
Dosage Form
-
Strength
500MG;EQ 5MG BASE
Approval Date
2023-07-31
Regulatory Status
RX
Drug Name
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
1GM;EQ 2.5MG BASE
Approval Date
2023-07-31
Active Ingredient
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
Application Number
205981
Product Number
2
Dosage Form
-
Strength
1GM;EQ 2.5MG BASE
Approval Date
2023-07-31
Regulatory Status
RX
Drug Name
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
1GM;EQ 5MG BASE
Approval Date
2023-07-31
Active Ingredient
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
Application Number
205981
Product Number
3
Dosage Form
-
Strength
1GM;EQ 5MG BASE
Approval Date
2023-07-31
Regulatory Status
RX
Drug Name
SCOPOLAMINE
Product Number
1
Dosage Form
-
Strength
1MG/72HR
Approval Date
2019-06-19
Active Ingredient
SCOPOLAMINE
Application Number
203753
Product Number
1
Dosage Form
-
Strength
1MG/72HR
Approval Date
2019-06-19
Regulatory Status
RX
Drug Name
SFROWASA
Product Number
2
Dosage Form
-
Strength
4GM/60ML
Approval Date
2008-06-20
Active Ingredient
MESALAMINE
Application Number
19618
Product Number
2
Dosage Form
-
Strength
4GM/60ML
Approval Date
2008-06-20
Regulatory Status
RX
Drug Name
SODIUM NITROPRUSSIDE
Product Number
1
Dosage Form
-
Strength
25MG/ML
Approval Date
2018-04-17
Active Ingredient
SODIUM NITROPRUSSIDE
Application Number
210763
Product Number
1
Dosage Form
-
Strength
25MG/ML
Approval Date
2018-04-17
Regulatory Status
RX
Drug Name
SOMA
Product Number
1
Dosage Form
-
Strength
350MG
Approval Date
1982-01-01
Active Ingredient
CARISOPRODOL
Application Number
11792
Product Number
1
Dosage Form
-
Strength
350MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
SOMA
Product Number
4
Dosage Form
-
Strength
250MG
Approval Date
2007-09-13
Active Ingredient
CARISOPRODOL
Application Number
11792
Product Number
4
Dosage Form
-
Strength
250MG
Approval Date
2007-09-13
Regulatory Status
RX
Drug Name
SORAFENIB TOSYLATE
Product Number
1
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
2020-09-10
Active Ingredient
SORAFENIB TOSYLATE
Application Number
207012
Product Number
1
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
2020-09-10
Regulatory Status
RX
Drug Name
SOTRADECOL
Product Number
1
Dosage Form
-
Strength
20MG/2ML (10MG/ML)
Approval Date
2004-11-12
Active Ingredient
SODIUM TETRADECYL SULFATE
Application Number
40541
Product Number
1
Dosage Form
-
Strength
20MG/2ML (10MG/ML)
Approval Date
2004-11-12
Regulatory Status
RX
Drug Name
SOTRADECOL
Product Number
2
Dosage Form
-
Strength
60MG/2ML (30MG/ML)
Approval Date
2004-11-12
Active Ingredient
SODIUM TETRADECYL SULFATE
Application Number
40541
Product Number
2
Dosage Form
-
Strength
60MG/2ML (30MG/ML)
Approval Date
2004-11-12
Regulatory Status
RX
Drug Name
SPIRONOLACTONE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2001-08-20
Active Ingredient
SPIRONOLACTONE
Application Number
40424
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2001-08-20
Regulatory Status
RX
Drug Name
SPIRONOLACTONE
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2001-08-20
Active Ingredient
SPIRONOLACTONE
Application Number
40424
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2001-08-20
Regulatory Status
RX
Drug Name
SPIRONOLACTONE
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2001-08-20
Active Ingredient
SPIRONOLACTONE
Application Number
40424
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2001-08-20
Regulatory Status
RX
Drug Name
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
25MG;25MG
Approval Date
1982-01-01
Active Ingredient
HYDROCHLOROTHIAZIDE; SPIRONOLACTONE
Application Number
86513
Product Number
1
Dosage Form
-
Strength
25MG;25MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
SUCRALFATE
Product Number
1
Dosage Form
-
Strength
1GM/10ML
Approval Date
2022-09-12
Active Ingredient
SUCRALFATE
Application Number
212913
Product Number
1
Dosage Form
-
Strength
1GM/10ML
Approval Date
2022-09-12
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
213915
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
213915
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 25MG BASE
Approval Date
2009-08-10
Active Ingredient
SUMATRIPTAN SUCCINATE
Application Number
77744
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2009-08-10
Regulatory Status
RX
Drug Name
SUMATRIPTAN SUCCINATE
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2009-08-10
Active Ingredient
SUMATRIPTAN SUCCINATE
Application Number
77744
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2009-08-10
Regulatory Status
RX
Drug Name
SUMATRIPTAN SUCCINATE
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2009-08-10
Active Ingredient
SUMATRIPTAN SUCCINATE
Application Number
77744
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2009-08-10
Regulatory Status
RX
Drug Name
SUNITINIB MALATE
Product Number
1
Dosage Form
-
Strength
EQ 12.5MG BASE
Approval Date
2021-12-06
Active Ingredient
SUNITINIB MALATE
Application Number
201275
Product Number
1
Dosage Form
-
Strength
EQ 12.5MG BASE
Approval Date
2021-12-06
Regulatory Status
RX
Drug Name
SUNITINIB MALATE
Product Number
2
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2021-12-06
Active Ingredient
SUNITINIB MALATE
Application Number
201275
Product Number
2
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2021-12-06
Regulatory Status
RX
Drug Name
SUNITINIB MALATE
Product Number
3
Dosage Form
-
Strength
EQ 37.5MG BASE
Approval Date
2021-12-06
Active Ingredient
SUNITINIB MALATE
Application Number
201275
Product Number
3
Dosage Form
-
Strength
EQ 37.5MG BASE
Approval Date
2021-12-06
Regulatory Status
RX
Drug Name
SUNITINIB MALATE
Product Number
4
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2021-12-06
Active Ingredient
SUNITINIB MALATE
Application Number
201275
Product Number
4
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2021-12-06
Regulatory Status
RX
Drug Name
SYMFI
Product Number
1
Dosage Form
-
Strength
600MG;300MG;300MG
Approval Date
2018-03-22
Active Ingredient
EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
Application Number
22142
Product Number
1
Dosage Form
-
Strength
600MG;300MG;300MG
Approval Date
2018-03-22
Regulatory Status
RX
Drug Name
TACROLIMUS
Product Number
1
Dosage Form
-
Strength
EQ 0.5MG BASE
Approval Date
2010-09-17
Active Ingredient
TACROLIMUS
Application Number
90596
Product Number
1
Dosage Form
-
Strength
EQ 0.5MG BASE
Approval Date
2010-09-17
Regulatory Status
RX
Drug Name
TACROLIMUS
Product Number
2
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2010-09-17
Active Ingredient
TACROLIMUS
Application Number
90596
Product Number
2
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2010-09-17
Regulatory Status
RX
Drug Name
TACROLIMUS
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2010-09-17
Active Ingredient
TACROLIMUS
Application Number
90596
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2010-09-17
Regulatory Status
RX
Drug Name
TAMOXIFEN CITRATE
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2003-02-20
Active Ingredient
TAMOXIFEN CITRATE
Application Number
74732
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2003-02-20
Regulatory Status
RX
Drug Name
TAMOXIFEN CITRATE
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2003-02-20
Active Ingredient
TAMOXIFEN CITRATE
Application Number
74732
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2003-02-20
Regulatory Status
RX
Drug Name
TELMISARTAN
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2014-07-07
Active Ingredient
TELMISARTAN
Application Number
202397
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2014-07-07
Regulatory Status
RX
Drug Name
TELMISARTAN
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2014-07-07
Active Ingredient
TELMISARTAN
Application Number
202397
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2014-07-07
Regulatory Status
RX
Drug Name
TELMISARTAN
Product Number
3
Dosage Form
-
Strength
80MG
Approval Date
2014-07-07
Active Ingredient
TELMISARTAN
Application Number
202397
Product Number
3
Dosage Form
-
Strength
80MG
Approval Date
2014-07-07
Regulatory Status
RX
Drug Name
TELMISARTAN AND AMLODIPINE
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE;40MG
Approval Date
2014-08-26
Active Ingredient
AMLODIPINE BESYLATE; TELMISARTAN
Application Number
202516
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE;40MG
Approval Date
2014-08-26
Regulatory Status
RX
Drug Name
TELMISARTAN AND AMLODIPINE
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE;40MG
Approval Date
2014-08-26
Active Ingredient
AMLODIPINE BESYLATE; TELMISARTAN
Application Number
202516
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE;40MG
Approval Date
2014-08-26
Regulatory Status
RX
Drug Name
TELMISARTAN AND AMLODIPINE
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE;80MG
Approval Date
2014-08-26
Active Ingredient
AMLODIPINE BESYLATE; TELMISARTAN
Application Number
202516
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE;80MG
Approval Date
2014-08-26
Regulatory Status
RX
Drug Name
TELMISARTAN AND AMLODIPINE
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE;80MG
Approval Date
2014-08-26
Active Ingredient
AMLODIPINE BESYLATE; TELMISARTAN
Application Number
202516
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE;80MG
Approval Date
2014-08-26
Regulatory Status
RX
Drug Name
TETRABENAZINE
Product Number
1
Dosage Form
-
Strength
12.5MG
Approval Date
2017-01-31
Active Ingredient
TETRABENAZINE
Application Number
207682
Product Number
1
Dosage Form
-
Strength
12.5MG
Approval Date
2017-01-31
Regulatory Status
RX
Drug Name
TETRABENAZINE
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
2017-01-31
Active Ingredient
TETRABENAZINE
Application Number
207682
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
2017-01-31
Regulatory Status
RX
Drug Name
THIAMINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2012-06-25
Active Ingredient
THIAMINE HYDROCHLORIDE
Application Number
91623
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2012-06-25
Regulatory Status
RX
Drug Name
THIORIDAZINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
1983-11-18
Active Ingredient
THIORIDAZINE HYDROCHLORIDE
Application Number
88004
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
1983-11-18
Regulatory Status
RX
Drug Name
THIORIDAZINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
1983-03-15
Active Ingredient
THIORIDAZINE HYDROCHLORIDE
Application Number
88004
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
1983-03-15
Regulatory Status
RX
Drug Name
THIORIDAZINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
25MG
Approval Date
1983-03-15
Active Ingredient
THIORIDAZINE HYDROCHLORIDE
Application Number
88004
Product Number
3
Dosage Form
-
Strength
25MG
Approval Date
1983-03-15
Regulatory Status
RX
Drug Name
THIORIDAZINE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
50MG
Approval Date
1983-03-15
Active Ingredient
THIORIDAZINE HYDROCHLORIDE
Application Number
88004
Product Number
4
Dosage Form
-
Strength
50MG
Approval Date
1983-03-15
Regulatory Status
RX
Drug Name
TICAGRELOR
Product Number
1
Dosage Form
-
Strength
60MG
Approval Date
2021-07-09
Active Ingredient
TICAGRELOR
Application Number
208597
Product Number
1
Dosage Form
-
Strength
60MG
Approval Date
2021-07-09
Regulatory Status
RX
Drug Name
TICAGRELOR
Product Number
2
Dosage Form
-
Strength
90MG
Approval Date
2021-07-09
Active Ingredient
TICAGRELOR
Application Number
208597
Product Number
2
Dosage Form
-
Strength
90MG
Approval Date
2021-07-09
Regulatory Status
RX
Drug Name
TIMOLOL MALEATE
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
1990-06-08
Active Ingredient
TIMOLOL MALEATE
Application Number
72668
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
1990-06-08
Regulatory Status
RX
Drug Name
TOBI
Product Number
1
Dosage Form
-
Strength
300MG/5ML
Approval Date
1997-12-22
Active Ingredient
TOBRAMYCIN
Application Number
50753
Product Number
1
Dosage Form
-
Strength
300MG/5ML
Approval Date
1997-12-22
Regulatory Status
RX
Drug Name
TOBI PODHALER
Product Number
1
Dosage Form
-
Strength
28MG
Approval Date
2013-03-22
Active Ingredient
TOBRAMYCIN
Application Number
201688
Product Number
1
Dosage Form
-
Strength
28MG
Approval Date
2013-03-22
Regulatory Status
RX
Drug Name
TOBRAMYCIN SULFATE
Product Number
1
Dosage Form
-
Strength
EQ 40MG BASE/ML
Approval Date
2008-03-11
Active Ingredient
TOBRAMYCIN SULFATE
Application Number
65407
Product Number
1
Dosage Form
-
Strength
EQ 40MG BASE/ML
Approval Date
2008-03-11
Regulatory Status
RX
Drug Name
TRANEXAMIC ACID
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2011-11-03
Active Ingredient
TRANEXAMIC ACID
Application Number
91657
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2011-11-03
Regulatory Status
RX
Drug Name
TRAVOPROST
Product Number
1
Dosage Form
-
Strength
0.004%
Approval Date
2017-07-07
Active Ingredient
TRAVOPROST
Application Number
205050
Product Number
1
Dosage Form
-
Strength
0.004%
Approval Date
2017-07-07
Regulatory Status
RX
Drug Name
TRETINOIN
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2015-08-13
Active Ingredient
TRETINOIN
Application Number
207955
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2015-08-13
Regulatory Status
RX
Drug Name
TRIAMCINOLONE ACETONIDE
Product Number
1
Dosage Form
-
Strength
40MG/ML
Approval Date
2022-11-02
Active Ingredient
TRIAMCINOLONE ACETONIDE
Application Number
212567
Product Number
1
Dosage Form
-
Strength
40MG/ML
Approval Date
2022-11-02
Regulatory Status
RX
Drug Name
TRIFLUOPERAZINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
1997-07-07
Active Ingredient
TRIFLUOPERAZINE HYDROCHLORIDE
Application Number
40209
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
1997-07-07
Regulatory Status
RX
Drug Name
TRIFLUOPERAZINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
1997-07-07
Active Ingredient
TRIFLUOPERAZINE HYDROCHLORIDE
Application Number
40209
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
1997-07-07
Regulatory Status
RX
Drug Name
TRIFLUOPERAZINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
1997-07-07
Active Ingredient
TRIFLUOPERAZINE HYDROCHLORIDE
Application Number
40209
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
1997-07-07
Regulatory Status
RX
Drug Name
TRIFLUOPERAZINE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
1997-07-07
Active Ingredient
TRIFLUOPERAZINE HYDROCHLORIDE
Application Number
40209
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
1997-07-07
Regulatory Status
RX
Drug Name
ULTIVA
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/VIAL
Approval Date
1996-07-12
Active Ingredient
REMIFENTANIL HYDROCHLORIDE
Application Number
20630
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/VIAL
Approval Date
1996-07-12
Regulatory Status
RX
Drug Name
ULTIVA
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE/VIAL
Approval Date
1996-07-12
Active Ingredient
REMIFENTANIL HYDROCHLORIDE
Application Number
20630
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE/VIAL
Approval Date
1996-07-12
Regulatory Status
RX
Drug Name
ULTIVA
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE/VIAL
Approval Date
1996-07-12
Active Ingredient
REMIFENTANIL HYDROCHLORIDE
Application Number
20630
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE/VIAL
Approval Date
1996-07-12
Regulatory Status
RX
Drug Name
VALACYCLOVIR HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
2010-05-24
Active Ingredient
VALACYCLOVIR HYDROCHLORIDE
Application Number
78518
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
2010-05-24
Regulatory Status
RX
Drug Name
VALACYCLOVIR HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 1GM BASE
Approval Date
2010-05-24
Active Ingredient
VALACYCLOVIR HYDROCHLORIDE
Application Number
78518
Product Number
2
Dosage Form
-
Strength
EQ 1GM BASE
Approval Date
2010-05-24
Regulatory Status
RX
Drug Name
VALSARTAN
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
2015-01-05
Active Ingredient
VALSARTAN
Application Number
90866
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
2015-01-05
Regulatory Status
RX
Drug Name
VALSARTAN
Product Number
2
Dosage Form
-
Strength
80MG
Approval Date
2015-01-05
Active Ingredient
VALSARTAN
Application Number
90866
Product Number
2
Dosage Form
-
Strength
80MG
Approval Date
2015-01-05
Regulatory Status
RX
Drug Name
VALSARTAN
Product Number
3
Dosage Form
-
Strength
160MG
Approval Date
2015-01-05
Active Ingredient
VALSARTAN
Application Number
90866
Product Number
3
Dosage Form
-
Strength
160MG
Approval Date
2015-01-05
Regulatory Status
RX
Drug Name
VALSARTAN
Product Number
4
Dosage Form
-
Strength
320MG
Approval Date
2015-01-05
Active Ingredient
VALSARTAN
Application Number
90866
Product Number
4
Dosage Form
-
Strength
320MG
Approval Date
2015-01-05
Regulatory Status
RX
Drug Name
VALSARTAN AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
12.5MG;80MG
Approval Date
2012-09-21
Active Ingredient
HYDROCHLOROTHIAZIDE; VALSARTAN
Application Number
78020
Product Number
1
Dosage Form
-
Strength
12.5MG;80MG
Approval Date
2012-09-21
Regulatory Status
RX
Drug Name
VALSARTAN AND HYDROCHLOROTHIAZIDE
Product Number
2
Dosage Form
-
Strength
12.5MG;160MG
Approval Date
2012-09-21
Active Ingredient
HYDROCHLOROTHIAZIDE; VALSARTAN
Application Number
78020
Product Number
2
Dosage Form
-
Strength
12.5MG;160MG
Approval Date
2012-09-21
Regulatory Status
RX
Drug Name
VALSARTAN AND HYDROCHLOROTHIAZIDE
Product Number
3
Dosage Form
-
Strength
25MG;160MG
Approval Date
2012-09-21
Active Ingredient
HYDROCHLOROTHIAZIDE; VALSARTAN
Application Number
78020
Product Number
3
Dosage Form
-
Strength
25MG;160MG
Approval Date
2012-09-21
Regulatory Status
RX
Drug Name
VALSARTAN AND HYDROCHLOROTHIAZIDE
Product Number
4
Dosage Form
-
Strength
12.5MG;320MG
Approval Date
2012-09-21
Active Ingredient
HYDROCHLOROTHIAZIDE; VALSARTAN
Application Number
78020
Product Number
4
Dosage Form
-
Strength
12.5MG;320MG
Approval Date
2012-09-21
Regulatory Status
RX
Drug Name
VALSARTAN AND HYDROCHLOROTHIAZIDE
Product Number
5
Dosage Form
-
Strength
25MG;320MG
Approval Date
2012-09-21
Active Ingredient
HYDROCHLOROTHIAZIDE; VALSARTAN
Application Number
78020
Product Number
5
Dosage Form
-
Strength
25MG;320MG
Approval Date
2012-09-21
Regulatory Status
RX
Drug Name
VANCOMYCIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2008-12-30
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
65397
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2008-12-30
Regulatory Status
RX
Drug Name
VANCOMYCIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
2008-12-30
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
65397
Product Number
2
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
2008-12-30
Regulatory Status
RX
Drug Name
VANCOMYCIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 5GM BASE/VIAL
Approval Date
2008-12-30
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
65432
Product Number
1
Dosage Form
-
Strength
EQ 5GM BASE/VIAL
Approval Date
2008-12-30
Regulatory Status
RX
Drug Name
VANCOMYCIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 10GM BASE/VIAL
Approval Date
2011-09-19
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
91554
Product Number
1
Dosage Form
-
Strength
EQ 10GM BASE/VIAL
Approval Date
2011-09-19
Regulatory Status
RX
Drug Name
VANCOMYCIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 750MG BASE/VIAL
Approval Date
2018-07-10
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
209481
Product Number
2
Dosage Form
-
Strength
EQ 750MG BASE/VIAL
Approval Date
2018-07-10
Regulatory Status
RX
Drug Name
VANCOMYCIN HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 1.25GM BASE/VIAL
Approval Date
2018-07-10
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
209481
Product Number
3
Dosage Form
-
Strength
EQ 1.25GM BASE/VIAL
Approval Date
2018-07-10
Regulatory Status
RX
Drug Name
VANCOMYCIN HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
EQ 1.5GM BASE/VIAL
Approval Date
2018-07-10
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
209481
Product Number
4
Dosage Form
-
Strength
EQ 1.5GM BASE/VIAL
Approval Date
2018-07-10
Regulatory Status
RX
Drug Name
VANCOMYCIN HYDROCHLORIDE
Product Number
5
Dosage Form
-
Strength
EQ 1.75GM BASE/VIAL
Approval Date
2024-06-26
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
209481
Product Number
5
Dosage Form
-
Strength
EQ 1.75GM BASE/VIAL
Approval Date
2024-06-26
Regulatory Status
RX
Drug Name
VANCOMYCIN HYDROCHLORIDE
Product Number
6
Dosage Form
-
Strength
EQ 2GM BASE/VIAL
Approval Date
2024-06-26
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
209481
Product Number
6
Dosage Form
-
Strength
EQ 2GM BASE/VIAL
Approval Date
2024-06-26
Regulatory Status
RX
Drug Name
VECURONIUM BROMIDE
Product Number
1
Dosage Form
-
Strength
10MG/VIAL
Approval Date
2010-05-11
Active Ingredient
VECURONIUM BROMIDE
Application Number
90243
Product Number
1
Dosage Form
-
Strength
10MG/VIAL
Approval Date
2010-05-11
Regulatory Status
RX
Drug Name
VECURONIUM BROMIDE
Product Number
2
Dosage Form
-
Strength
20MG/VIAL
Approval Date
2010-05-11
Active Ingredient
VECURONIUM BROMIDE
Application Number
90243
Product Number
2
Dosage Form
-
Strength
20MG/VIAL
Approval Date
2010-05-11
Regulatory Status
RX
Drug Name
VERAPAMIL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
120MG
Approval Date
1999-04-20
Active Ingredient
VERAPAMIL HYDROCHLORIDE
Application Number
75138
Product Number
1
Dosage Form
-
Strength
120MG
Approval Date
1999-04-20
Regulatory Status
RX
Drug Name
VERAPAMIL HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
180MG
Approval Date
1999-04-20
Active Ingredient
VERAPAMIL HYDROCHLORIDE
Application Number
75138
Product Number
2
Dosage Form
-
Strength
180MG
Approval Date
1999-04-20
Regulatory Status
RX
Drug Name
VERAPAMIL HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
240MG
Approval Date
1999-04-20
Active Ingredient
VERAPAMIL HYDROCHLORIDE
Application Number
75138
Product Number
3
Dosage Form
-
Strength
240MG
Approval Date
1999-04-20
Regulatory Status
RX
Drug Name
VIAGRA
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
1998-03-27
Active Ingredient
SILDENAFIL CITRATE
Application Number
20895
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
1998-03-27
Regulatory Status
RX
Drug Name
VIAGRA
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
1998-03-27
Active Ingredient
SILDENAFIL CITRATE
Application Number
20895
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
1998-03-27
Regulatory Status
RX
Drug Name
VIAGRA
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
1998-03-27
Active Ingredient
SILDENAFIL CITRATE
Application Number
20895
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
1998-03-27
Regulatory Status
RX
Drug Name
VORICONAZOLE
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2010-04-22
Active Ingredient
VORICONAZOLE
Application Number
90547
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2010-04-22
Regulatory Status
RX
Drug Name
VORICONAZOLE
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
2010-04-22
Active Ingredient
VORICONAZOLE
Application Number
90547
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
2010-04-22
Regulatory Status
RX
Drug Name
VUSION
Product Number
1
Dosage Form
-
Strength
0.25%;81.35%;15%
Approval Date
2006-02-16
Active Ingredient
MICONAZOLE NITRATE; WHITE PETROLATUM; ZINC OXIDE
Application Number
21026
Product Number
1
Dosage Form
-
Strength
0.25%;81.35%;15%
Approval Date
2006-02-16
Regulatory Status
RX
Drug Name
WIXELA INHUB
Product Number
1
Dosage Form
-
Strength
0.1MG/INH;EQ 0.05MG BASE/INH
Approval Date
2019-01-30
Active Ingredient
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Application Number
208891
Product Number
1
Dosage Form
-
Strength
0.1MG/INH;EQ 0.05MG BASE/INH
Approval Date
2019-01-30
Regulatory Status
RX
Drug Name
WIXELA INHUB
Product Number
2
Dosage Form
-
Strength
0.25MG/INH;EQ 0.05MG BASE/INH
Approval Date
2019-01-30
Active Ingredient
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Application Number
208891
Product Number
2
Dosage Form
-
Strength
0.25MG/INH;EQ 0.05MG BASE/INH
Approval Date
2019-01-30
Regulatory Status
RX
Drug Name
WIXELA INHUB
Product Number
3
Dosage Form
-
Strength
0.5MG/INH;EQ 0.05MG BASE/INH
Approval Date
2019-01-30
Active Ingredient
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Application Number
208891
Product Number
3
Dosage Form
-
Strength
0.5MG/INH;EQ 0.05MG BASE/INH
Approval Date
2019-01-30
Regulatory Status
RX
Drug Name
XULANE
Product Number
1
Dosage Form
-
Strength
0.035MG/24HR;0.15MG/24HR
Approval Date
2014-04-16
Active Ingredient
ETHINYL ESTRADIOL; NORELGESTROMIN
Application Number
200910
Product Number
1
Dosage Form
-
Strength
0.035MG/24HR;0.15MG/24HR
Approval Date
2014-04-16
Regulatory Status
RX
Drug Name
ZOLEDRONIC ACID
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE/5ML
Approval Date
2013-03-04
Active Ingredient
ZOLEDRONIC ACID
Application Number
202650
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE/5ML
Approval Date
2013-03-04
Regulatory Status
RX
Drug Name
ZOLEDRONIC ACID
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/100ML
Approval Date
2017-02-14
Active Ingredient
ZOLEDRONIC ACID
Application Number
203841
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/100ML
Approval Date
2017-02-14
Regulatory Status
RX
Drug Name
ZOLEDRONIC ACID
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/100ML
Approval Date
2017-10-27
Active Ingredient
ZOLEDRONIC ACID
Application Number
205254
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/100ML
Approval Date
2017-10-27
Regulatory Status
RX
Drug Name
ZOLOFT
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
1991-12-30
Active Ingredient
SERTRALINE HYDROCHLORIDE
Application Number
19839
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
1991-12-30
Regulatory Status
RX
Drug Name
ZOLOFT
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
1991-12-30
Active Ingredient
SERTRALINE HYDROCHLORIDE
Application Number
19839
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
1991-12-30
Regulatory Status
RX
Drug Name
ZOLOFT
Product Number
5
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
1996-03-06
Active Ingredient
SERTRALINE HYDROCHLORIDE
Application Number
19839
Product Number
5
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
1996-03-06
Regulatory Status
RX
Drug Name
ZOLOFT
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE/ML
Approval Date
1999-12-07
Active Ingredient
SERTRALINE HYDROCHLORIDE
Application Number
20990
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE/ML
Approval Date
1999-12-07
Regulatory Status
RX
Drug Name
ZONALON
Product Number
1
Dosage Form
-
Strength
5%
Approval Date
1994-04-01
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
20126
Product Number
1
Dosage Form
-
Strength
5%
Approval Date
1994-04-01
Regulatory Status
RX
Drug Status Breakdown
511 total- RX
Official Source
FDA approved drug data is based on publicly available U.S. Food and Drug Administration Orange Book information.
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Drug Name
ABACAVIR SULFATE
Application Number
91294
Product Number
1
Active Ingredient
ABACAVIR SULFATE
Dosage Form
-
Strength
EQ 300MG BASE
FDA Approved Drug Data
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