GLAND PHARMA LIMITED
FDA Approved Drugs
GLAND PHARMA LIMITED
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 240
- Latest Approval Date Jul 31, 2026
- Data Source FDA
- First Approval Date Jul 27, 2004
Company Overview
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Company Snapshot
GLAND PHARMA LIMITED
6-3-865/1/2, Greenland Apartments Ameerpet, Hyderabad - 500016
India
glandpharma.com/ gland@glandpharma.com View on MapFDA Approved Drug Records ( 240 records )
Drug Name
ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
500MG/50ML (10MG/ML)
Approval Date
2025-04-02
Active Ingredient
ACETAMINOPHEN
Application Number
219215
Product Number
1
Dosage Form
-
Strength
500MG/50ML (10MG/ML)
Approval Date
2025-04-02
Regulatory Status
RX
Drug Name
ACETAMINOPHEN
Product Number
2
Dosage Form
-
Strength
1GM/100ML (10MG/ML)
Approval Date
2025-04-02
Active Ingredient
ACETAMINOPHEN
Application Number
219215
Product Number
2
Dosage Form
-
Strength
1GM/100ML (10MG/ML)
Approval Date
2025-04-02
Regulatory Status
RX
Drug Name
ACETAZOLAMIDE SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2025-06-17
Active Ingredient
ACETAZOLAMIDE SODIUM
Application Number
219775
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2025-06-17
Regulatory Status
RX
Drug Name
ADENOSINE
Product Number
1
Dosage Form
-
Strength
3MG/ML
Approval Date
2007-06-14
Active Ingredient
ADENOSINE
Application Number
77283
Product Number
1
Dosage Form
-
Strength
3MG/ML
Approval Date
2007-06-14
Regulatory Status
RX
Drug Name
ADENOSINE
Product Number
1
Dosage Form
-
Strength
3MG/ML
Approval Date
2018-02-16
Active Ingredient
ADENOSINE
Application Number
206778
Product Number
1
Dosage Form
-
Strength
3MG/ML
Approval Date
2018-02-16
Regulatory Status
RX
Drug Name
ALCAFTADINE
Product Number
1
Dosage Form
-
Strength
0.25%
Approval Date
2024-03-01
Active Ingredient
ALCAFTADINE
Application Number
209706
Product Number
1
Dosage Form
-
Strength
0.25%
Approval Date
2024-03-01
Regulatory Status
OTC
Drug Name
ALLOPURINOL SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2022-01-26
Active Ingredient
ALLOPURINOL SODIUM
Application Number
212363
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2022-01-26
Regulatory Status
RX
Drug Name
AMIODARONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
50MG/ML
Approval Date
2005-04-20
Active Ingredient
AMIODARONE HYDROCHLORIDE
Application Number
77161
Product Number
1
Dosage Form
-
Strength
50MG/ML
Approval Date
2005-04-20
Regulatory Status
RX
Drug Name
ANGIOTENSIN ll ACETATE
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)
Approval Date
2025-06-03
Active Ingredient
ANGIOTENSIN II ACETATE
Application Number
216966
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)
Approval Date
2025-06-03
Regulatory Status
RX
Drug Name
ARGATROBAN
Product Number
1
Dosage Form
-
Strength
50MG/50ML (1MG/ML)
Approval Date
2023-07-31
Active Ingredient
ARGATROBAN
Application Number
217848
Product Number
1
Dosage Form
-
Strength
50MG/50ML (1MG/ML)
Approval Date
2023-07-31
Regulatory Status
RX
Drug Name
ARGATROBAN IN SODIUM CHLORIDE
Product Number
1
Dosage Form
-
Strength
125MG/125ML (1MG/ML)
Approval Date
2017-05-22
Active Ingredient
ARGATROBAN
Application Number
205570
Product Number
1
Dosage Form
-
Strength
125MG/125ML (1MG/ML)
Approval Date
2017-05-22
Regulatory Status
RX
Drug Name
ARSENIC TRIOXIDE
Product Number
1
Dosage Form
-
Strength
2MG/ML
Approval Date
2021-10-07
Active Ingredient
ARSENIC TRIOXIDE
Application Number
215059
Product Number
1
Dosage Form
-
Strength
2MG/ML
Approval Date
2021-10-07
Regulatory Status
RX
Drug Name
ARSENIC TRIOXIDE
Product Number
2
Dosage Form
-
Strength
1MG/ML
Approval Date
2022-04-22
Active Ingredient
ARSENIC TRIOXIDE
Application Number
215059
Product Number
2
Dosage Form
-
Strength
1MG/ML
Approval Date
2022-04-22
Regulatory Status
RX
Drug Name
ATROPINE SULFATE
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
2026-07-31
Active Ingredient
ATROPINE SULFATE
Application Number
219996
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
2026-07-31
Regulatory Status
RX
Drug Name
AZELASTINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2020-02-25
Active Ingredient
AZELASTINE HYDROCHLORIDE
Application Number
210092
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2020-02-25
Regulatory Status
RX
Drug Name
AZITHROMYCIN
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2009-11-09
Active Ingredient
AZITHROMYCIN
Application Number
65501
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2009-11-09
Regulatory Status
RX
Drug Name
BIMATOPROST
Product Number
1
Dosage Form
-
Strength
0.01%
Approval Date
-
Active Ingredient
BIMATOPROST
Application Number
209797
Product Number
1
Dosage Form
-
Strength
0.01%
Approval Date
-
Regulatory Status
Unclassified
Drug Name
BIMATOPROST
Product Number
1
Dosage Form
-
Strength
0.03%
Approval Date
2019-03-22
Active Ingredient
BIMATOPROST
Application Number
210126
Product Number
1
Dosage Form
-
Strength
0.03%
Approval Date
2019-03-22
Regulatory Status
RX
Drug Name
BORTEZOMIB
Product Number
1
Dosage Form
-
Strength
1MG/VIAL
Approval Date
2026-01-06
Active Ingredient
BORTEZOMIB
Application Number
219167
Product Number
1
Dosage Form
-
Strength
1MG/VIAL
Approval Date
2026-01-06
Regulatory Status
RX
Drug Name
BORTEZOMIB
Product Number
2
Dosage Form
-
Strength
2.5MG/VIAL
Approval Date
2026-01-06
Active Ingredient
BORTEZOMIB
Application Number
219167
Product Number
2
Dosage Form
-
Strength
2.5MG/VIAL
Approval Date
2026-01-06
Regulatory Status
RX
Drug Name
BRIMONIDINE TARTRATE
Product Number
1
Dosage Form
-
Strength
0.1%
Approval Date
2026-03-11
Active Ingredient
BRIMONIDINE TARTRATE
Application Number
219219
Product Number
1
Dosage Form
-
Strength
0.1%
Approval Date
2026-03-11
Regulatory Status
RX
Drug Name
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE
Product Number
1
Dosage Form
-
Strength
0.2%;EQ 0.5% BASE
Approval Date
2026-06-11
Active Ingredient
BRIMONIDINE TARTRATE; TIMOLOL MALEATE
Application Number
219166
Product Number
1
Dosage Form
-
Strength
0.2%;EQ 0.5% BASE
Approval Date
2026-06-11
Regulatory Status
RX
Drug Name
BROMFENAC SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 0.09% ACID
Approval Date
2020-03-17
Active Ingredient
BROMFENAC SODIUM
Application Number
211029
Product Number
1
Dosage Form
-
Strength
EQ 0.09% ACID
Approval Date
2020-03-17
Regulatory Status
RX
Drug Name
BUMETANIDE
Product Number
1
Dosage Form
-
Strength
0.25MG/ML
Approval Date
2022-05-26
Active Ingredient
BUMETANIDE
Application Number
216434
Product Number
1
Dosage Form
-
Strength
0.25MG/ML
Approval Date
2022-05-26
Regulatory Status
RX
Drug Name
CALCITRIOL
Product Number
1
Dosage Form
-
Strength
0.001MG/ML
Approval Date
2020-02-03
Active Ingredient
CALCITRIOL
Application Number
211030
Product Number
1
Dosage Form
-
Strength
0.001MG/ML
Approval Date
2020-02-03
Regulatory Status
RX
Drug Name
CANGRELOR
Product Number
1
Dosage Form
-
Strength
50MG/VIAL
Approval Date
2025-08-11
Active Ingredient
CANGRELOR
Application Number
213551
Product Number
1
Dosage Form
-
Strength
50MG/VIAL
Approval Date
2025-08-11
Regulatory Status
RX
Drug Name
CARBOPLATIN
Product Number
1
Dosage Form
-
Strength
50MG/5ML (10MG/ML)
Approval Date
2017-02-15
Active Ingredient
CARBOPLATIN
Application Number
207324
Product Number
1
Dosage Form
-
Strength
50MG/5ML (10MG/ML)
Approval Date
2017-02-15
Regulatory Status
RX
Drug Name
CARBOPLATIN
Product Number
2
Dosage Form
-
Strength
150MG/15ML (10MG/ML)
Approval Date
2017-02-15
Active Ingredient
CARBOPLATIN
Application Number
207324
Product Number
2
Dosage Form
-
Strength
150MG/15ML (10MG/ML)
Approval Date
2017-02-15
Regulatory Status
RX
Drug Name
CARBOPLATIN
Product Number
3
Dosage Form
-
Strength
450MG/45ML (10MG/ML)
Approval Date
2017-02-15
Active Ingredient
CARBOPLATIN
Application Number
207324
Product Number
3
Dosage Form
-
Strength
450MG/45ML (10MG/ML)
Approval Date
2017-02-15
Regulatory Status
RX
Drug Name
CARBOPLATIN
Product Number
4
Dosage Form
-
Strength
600MG/60ML (10MG/ML)
Approval Date
2017-02-15
Active Ingredient
CARBOPLATIN
Application Number
207324
Product Number
4
Dosage Form
-
Strength
600MG/60ML (10MG/ML)
Approval Date
2017-02-15
Regulatory Status
RX
Drug Name
CARBOPROST TROMETHAMINE
Product Number
1
Dosage Form
-
Strength
EQ 0.25MG BASE/ML
Approval Date
2023-08-07
Active Ingredient
CARBOPROST TROMETHAMINE
Application Number
217657
Product Number
1
Dosage Form
-
Strength
EQ 0.25MG BASE/ML
Approval Date
2023-08-07
Regulatory Status
RX
Drug Name
CASPOFUNGIN ACETATE
Product Number
1
Dosage Form
-
Strength
50MG/VIAL
Approval Date
2017-09-29
Active Ingredient
CASPOFUNGIN ACETATE
Application Number
207092
Product Number
1
Dosage Form
-
Strength
50MG/VIAL
Approval Date
2017-09-29
Regulatory Status
RX
Drug Name
CASPOFUNGIN ACETATE
Product Number
2
Dosage Form
-
Strength
70MG/VIAL
Approval Date
2017-09-29
Active Ingredient
CASPOFUNGIN ACETATE
Application Number
207092
Product Number
2
Dosage Form
-
Strength
70MG/VIAL
Approval Date
2017-09-29
Regulatory Status
RX
Drug Name
CETRORELIX ACETATE
Product Number
1
Dosage Form
-
Strength
EQ 0.25MG BASE/VIAL
Approval Date
2024-04-25
Active Ingredient
CETRORELIX ACETATE
Application Number
218150
Product Number
1
Dosage Form
-
Strength
EQ 0.25MG BASE/VIAL
Approval Date
2024-04-25
Regulatory Status
RX
Drug Name
CHLOROTHIAZIDE SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2024-10-03
Active Ingredient
CHLOROTHIAZIDE SODIUM
Application Number
218630
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2024-10-03
Regulatory Status
RX
Drug Name
CHLORPROMAZINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
25MG/ML
Approval Date
2024-10-04
Active Ingredient
CHLORPROMAZINE HYDROCHLORIDE
Application Number
216911
Product Number
1
Dosage Form
-
Strength
25MG/ML
Approval Date
2024-10-04
Regulatory Status
RX
Drug Name
CISATRACURIUM BESYLATE
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE/ML
Approval Date
2022-05-24
Active Ingredient
CISATRACURIUM BESYLATE
Application Number
215516
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE/ML
Approval Date
2022-05-24
Regulatory Status
RX
Drug Name
CISATRACURIUM BESYLATE
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE/ML
Approval Date
2022-05-24
Active Ingredient
CISATRACURIUM BESYLATE
Application Number
215516
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE/ML
Approval Date
2022-05-24
Regulatory Status
RX
Drug Name
CISATRACURIUM BESYLATE
Product Number
3
Dosage Form
-
Strength
EQ 2MG BASE/ML
Approval Date
2022-12-14
Active Ingredient
CISATRACURIUM BESYLATE
Application Number
215516
Product Number
3
Dosage Form
-
Strength
EQ 2MG BASE/ML
Approval Date
2022-12-14
Regulatory Status
RX
Drug Name
CISPLATIN
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2017-03-17
Active Ingredient
CISPLATIN
Application Number
207323
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2017-03-17
Regulatory Status
RX
Drug Name
CLOFARABINE
Product Number
1
Dosage Form
-
Strength
20MG/20ML (1MG/ML)
Approval Date
2018-10-31
Active Ingredient
CLOFARABINE
Application Number
207831
Product Number
1
Dosage Form
-
Strength
20MG/20ML (1MG/ML)
Approval Date
2018-10-31
Regulatory Status
RX
Drug Name
CYANOCOBALAMIN
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2020-09-24
Active Ingredient
CYANOCOBALAMIN
Application Number
214390
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2020-09-24
Regulatory Status
RX
Drug Name
CYTARABINE
Product Number
1
Dosage Form
-
Strength
100MG/VIAL
Approval Date
2019-12-23
Active Ingredient
CYTARABINE
Application Number
211937
Product Number
1
Dosage Form
-
Strength
100MG/VIAL
Approval Date
2019-12-23
Regulatory Status
RX
Drug Name
CYTARABINE
Product Number
1
Dosage Form
-
Strength
2GM/VIAL
Approval Date
2019-12-23
Active Ingredient
CYTARABINE
Application Number
211938
Product Number
1
Dosage Form
-
Strength
2GM/VIAL
Approval Date
2019-12-23
Regulatory Status
RX
Drug Name
DECITABINE
Product Number
1
Dosage Form
-
Strength
50MG/VIAL
Approval Date
2020-11-23
Active Ingredient
DECITABINE
Application Number
205539
Product Number
1
Dosage Form
-
Strength
50MG/VIAL
Approval Date
2020-11-23
Regulatory Status
RX
Drug Name
DEFEROXAMINE MESYLATE
Product Number
1
Dosage Form
-
Strength
500MG/VIAL
Approval Date
2017-09-29
Active Ingredient
DEFEROXAMINE MESYLATE
Application Number
207384
Product Number
1
Dosage Form
-
Strength
500MG/VIAL
Approval Date
2017-09-29
Regulatory Status
RX
Drug Name
DEFEROXAMINE MESYLATE
Product Number
2
Dosage Form
-
Strength
2GM/VIAL
Approval Date
2017-09-29
Active Ingredient
DEFEROXAMINE MESYLATE
Application Number
207384
Product Number
2
Dosage Form
-
Strength
2GM/VIAL
Approval Date
2017-09-29
Regulatory Status
RX
Drug Name
DESMOPRESSIN ACETATE
Product Number
1
Dosage Form
-
Strength
0.004MG/ML
Approval Date
2023-03-20
Active Ingredient
DESMOPRESSIN ACETATE
Application Number
216904
Product Number
1
Dosage Form
-
Strength
0.004MG/ML
Approval Date
2023-03-20
Regulatory Status
RX
Drug Name
DESMOPRESSIN ACETATE
Product Number
1
Dosage Form
-
Strength
0.004MG/ML
Approval Date
2022-11-16
Active Ingredient
DESMOPRESSIN ACETATE
Application Number
216922
Product Number
1
Dosage Form
-
Strength
0.004MG/ML
Approval Date
2022-11-16
Regulatory Status
RX
Drug Name
DEXAMETHASONE SODIUM PHOSPHATE
Product Number
1
Dosage Form
-
Strength
EQ 4MG PHOSPHATE/ML
Approval Date
2021-08-04
Active Ingredient
DEXAMETHASONE SODIUM PHOSPHATE
Application Number
215654
Product Number
1
Dosage Form
-
Strength
EQ 4MG PHOSPHATE/ML
Approval Date
2021-08-04
Regulatory Status
RX
Drug Name
DEXAMETHASONE SODIUM PHOSPHATE
Product Number
2
Dosage Form
-
Strength
EQ 10MG PHOSPHATE/ML
Approval Date
2023-09-25
Active Ingredient
DEXAMETHASONE SODIUM PHOSPHATE
Application Number
215654
Product Number
2
Dosage Form
-
Strength
EQ 10MG PHOSPHATE/ML
Approval Date
2023-09-25
Regulatory Status
RX
Drug Name
DEXMEDETOMIDINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)
Approval Date
2015-08-20
Active Ingredient
DEXMEDETOMIDINE HYDROCHLORIDE
Application Number
202126
Product Number
1
Dosage Form
-
Strength
EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)
Approval Date
2015-08-20
Regulatory Status
RX
Drug Name
DEXMEDETOMIDINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)
Approval Date
2020-06-03
Active Ingredient
DEXMEDETOMIDINE HYDROCHLORIDE
Application Number
209307
Product Number
1
Dosage Form
-
Strength
EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)
Approval Date
2020-06-03
Regulatory Status
RX
Drug Name
DEXMEDETOMIDINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)
Approval Date
2020-06-03
Active Ingredient
DEXMEDETOMIDINE HYDROCHLORIDE
Application Number
209307
Product Number
2
Dosage Form
-
Strength
EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)
Approval Date
2020-06-03
Regulatory Status
RX
Drug Name
DEXRAZOXANE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2016-11-28
Active Ingredient
DEXRAZOXANE HYDROCHLORIDE
Application Number
207321
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2016-11-28
Regulatory Status
RX
Drug Name
DEXRAZOXANE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 250MG BASE/VIAL
Approval Date
2019-12-16
Active Ingredient
DEXRAZOXANE HYDROCHLORIDE
Application Number
207321
Product Number
2
Dosage Form
-
Strength
EQ 250MG BASE/VIAL
Approval Date
2019-12-16
Regulatory Status
RX
Drug Name
DIHYDROERGOTAMINE MESYLATE
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2023-08-18
Active Ingredient
DIHYDROERGOTAMINE MESYLATE
Application Number
215623
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2023-08-18
Regulatory Status
RX
Drug Name
DIPHENHYDRAMINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
50MG/ML
Approval Date
2024-03-20
Active Ingredient
DIPHENHYDRAMINE HYDROCHLORIDE
Application Number
218448
Product Number
1
Dosage Form
-
Strength
50MG/ML
Approval Date
2024-03-20
Regulatory Status
RX
Drug Name
DOCETAXEL
Product Number
1
Dosage Form
-
Strength
20MG/2ML (10MG/ML)
Approval Date
2021-07-01
Active Ingredient
DOCETAXEL
Application Number
213510
Product Number
1
Dosage Form
-
Strength
20MG/2ML (10MG/ML)
Approval Date
2021-07-01
Regulatory Status
RX
Drug Name
DOCETAXEL
Product Number
2
Dosage Form
-
Strength
80MG/8ML (10MG/ML)
Approval Date
2021-07-01
Active Ingredient
DOCETAXEL
Application Number
213510
Product Number
2
Dosage Form
-
Strength
80MG/8ML (10MG/ML)
Approval Date
2021-07-01
Regulatory Status
RX
Drug Name
DOCETAXEL
Product Number
3
Dosage Form
-
Strength
160MG/16ML (10MG/ML)
Approval Date
2021-07-01
Active Ingredient
DOCETAXEL
Application Number
213510
Product Number
3
Dosage Form
-
Strength
160MG/16ML (10MG/ML)
Approval Date
2021-07-01
Regulatory Status
RX
Drug Name
DORZOLAMIDE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 2% BASE
Approval Date
2022-01-27
Active Ingredient
DORZOLAMIDE HYDROCHLORIDE
Application Number
215660
Product Number
1
Dosage Form
-
Strength
EQ 2% BASE
Approval Date
2022-01-27
Regulatory Status
RX
Drug Name
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
Product Number
1
Dosage Form
-
Strength
EQ 2% BASE;EQ 0.5% BASE
Approval Date
2022-09-19
Active Ingredient
DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE
Application Number
215520
Product Number
1
Dosage Form
-
Strength
EQ 2% BASE;EQ 0.5% BASE
Approval Date
2022-09-19
Regulatory Status
RX
Drug Name
DOXERCALCIFEROL
Product Number
1
Dosage Form
-
Strength
4MCG/2ML (2MCG/ML)
Approval Date
2019-09-26
Active Ingredient
DOXERCALCIFEROL
Application Number
210452
Product Number
1
Dosage Form
-
Strength
4MCG/2ML (2MCG/ML)
Approval Date
2019-09-26
Regulatory Status
RX
Drug Name
DOXORUBICIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
2MG/ML
Approval Date
2017-08-11
Active Ingredient
DOXORUBICIN HYDROCHLORIDE
Application Number
209825
Product Number
1
Dosage Form
-
Strength
2MG/ML
Approval Date
2017-08-11
Regulatory Status
RX
Drug Name
DOXYCYCLINE HYCLATE
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE/VIAL
Approval Date
2023-04-12
Active Ingredient
DOXYCYCLINE HYCLATE
Application Number
215583
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE/VIAL
Approval Date
2023-04-12
Regulatory Status
RX
Drug Name
EDARAVONE
Product Number
1
Dosage Form
-
Strength
30MG/100ML (0.3MG/ML)
Approval Date
2024-05-06
Active Ingredient
EDARAVONE
Application Number
216199
Product Number
1
Dosage Form
-
Strength
30MG/100ML (0.3MG/ML)
Approval Date
2024-05-06
Regulatory Status
RX
Drug Name
EDARAVONE
Product Number
2
Dosage Form
-
Strength
60MG/100ML (0.6MG/ML)
Approval Date
2024-05-06
Active Ingredient
EDARAVONE
Application Number
216199
Product Number
2
Dosage Form
-
Strength
60MG/100ML (0.6MG/ML)
Approval Date
2024-05-06
Regulatory Status
Discontinued
Drug Name
ENOXAPARIN SODIUM (PRESERVATIVE FREE)
Product Number
1
Dosage Form
-
Strength
30MG/0.3ML (100MG/ML)
Approval Date
2018-09-28
Active Ingredient
ENOXAPARIN SODIUM
Application Number
78990
Product Number
1
Dosage Form
-
Strength
30MG/0.3ML (100MG/ML)
Approval Date
2018-09-28
Regulatory Status
RX
Drug Name
ENOXAPARIN SODIUM (PRESERVATIVE FREE)
Product Number
2
Dosage Form
-
Strength
40MG/0.4ML (100MG/ML)
Approval Date
2018-09-28
Active Ingredient
ENOXAPARIN SODIUM
Application Number
78990
Product Number
2
Dosage Form
-
Strength
40MG/0.4ML (100MG/ML)
Approval Date
2018-09-28
Regulatory Status
RX
Drug Name
ENOXAPARIN SODIUM (PRESERVATIVE FREE)
Product Number
3
Dosage Form
-
Strength
60MG/0.6ML (100MG/ML)
Approval Date
2018-09-28
Active Ingredient
ENOXAPARIN SODIUM
Application Number
78990
Product Number
3
Dosage Form
-
Strength
60MG/0.6ML (100MG/ML)
Approval Date
2018-09-28
Regulatory Status
RX
Drug Name
ENOXAPARIN SODIUM (PRESERVATIVE FREE)
Product Number
4
Dosage Form
-
Strength
80MG/0.8ML (100MG/ML)
Approval Date
2018-09-28
Active Ingredient
ENOXAPARIN SODIUM
Application Number
78990
Product Number
4
Dosage Form
-
Strength
80MG/0.8ML (100MG/ML)
Approval Date
2018-09-28
Regulatory Status
RX
Drug Name
ENOXAPARIN SODIUM (PRESERVATIVE FREE)
Product Number
5
Dosage Form
-
Strength
100MG/ML (100MG/ML)
Approval Date
2018-09-28
Active Ingredient
ENOXAPARIN SODIUM
Application Number
78990
Product Number
5
Dosage Form
-
Strength
100MG/ML (100MG/ML)
Approval Date
2018-09-28
Regulatory Status
RX
Drug Name
ENOXAPARIN SODIUM (PRESERVATIVE FREE)
Product Number
6
Dosage Form
-
Strength
120MG/0.8ML (150MG/ML)
Approval Date
2018-09-28
Active Ingredient
ENOXAPARIN SODIUM
Application Number
78990
Product Number
6
Dosage Form
-
Strength
120MG/0.8ML (150MG/ML)
Approval Date
2018-09-28
Regulatory Status
RX
Drug Name
ENOXAPARIN SODIUM (PRESERVATIVE FREE)
Product Number
7
Dosage Form
-
Strength
150MG/ML (150MG/ML)
Approval Date
2018-09-28
Active Ingredient
ENOXAPARIN SODIUM
Application Number
78990
Product Number
7
Dosage Form
-
Strength
150MG/ML (150MG/ML)
Approval Date
2018-09-28
Regulatory Status
RX
Drug Name
EPHEDRINE SULFATE
Product Number
1
Dosage Form
-
Strength
50MG/ML (50MG/ML)
Approval Date
2022-02-25
Active Ingredient
EPHEDRINE SULFATE
Application Number
216146
Product Number
1
Dosage Form
-
Strength
50MG/ML (50MG/ML)
Approval Date
2022-02-25
Regulatory Status
RX
Drug Name
EPHEDRINE SULFATE
Product Number
1
Dosage Form
-
Strength
50MG/10ML (5MG/ML)
Approval Date
2025-01-16
Active Ingredient
EPHEDRINE SULFATE
Application Number
218211
Product Number
1
Dosage Form
-
Strength
50MG/10ML (5MG/ML)
Approval Date
2025-01-16
Regulatory Status
RX
Drug Name
EPINEPHRINE
Product Number
1
Dosage Form
-
Strength
1MG/ML (1MG/ML)
Approval Date
2025-06-03
Active Ingredient
EPINEPHRINE
Application Number
218144
Product Number
1
Dosage Form
-
Strength
1MG/ML (1MG/ML)
Approval Date
2025-06-03
Regulatory Status
RX
Drug Name
EPINEPHRINE
Product Number
1
Dosage Form
-
Strength
10MG/10ML (1MG/ML)
Approval Date
2025-02-06
Active Ingredient
EPINEPHRINE
Application Number
219239
Product Number
1
Dosage Form
-
Strength
10MG/10ML (1MG/ML)
Approval Date
2025-02-06
Regulatory Status
RX
Drug Name
EPINEPHRINE
Product Number
2
Dosage Form
-
Strength
30MG/30ML (1MG/ML)
Approval Date
2025-10-02
Active Ingredient
EPINEPHRINE
Application Number
219239
Product Number
2
Dosage Form
-
Strength
30MG/30ML (1MG/ML)
Approval Date
2025-10-02
Regulatory Status
RX
Drug Name
EPOPROSTENOL SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 0.5MG BASE/VIAL
Approval Date
2025-12-29
Active Ingredient
EPOPROSTENOL SODIUM
Application Number
219237
Product Number
1
Dosage Form
-
Strength
EQ 0.5MG BASE/VIAL
Approval Date
2025-12-29
Regulatory Status
RX
Drug Name
EPOPROSTENOL SODIUM
Product Number
2
Dosage Form
-
Strength
EQ 1.5MG BASE/VIAL
Approval Date
2025-12-29
Active Ingredient
EPOPROSTENOL SODIUM
Application Number
219237
Product Number
2
Dosage Form
-
Strength
EQ 1.5MG BASE/VIAL
Approval Date
2025-12-29
Regulatory Status
RX
Drug Name
ERIBULIN MESYLATE
Product Number
1
Dosage Form
-
Strength
1MG/2ML (0.5MG/ML)
Approval Date
2024-04-05
Active Ingredient
ERIBULIN MESYLATE
Application Number
218047
Product Number
1
Dosage Form
-
Strength
1MG/2ML (0.5MG/ML)
Approval Date
2024-04-05
Regulatory Status
RX
Drug Name
ERTAPENEM SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
2021-03-26
Active Ingredient
ERTAPENEM SODIUM
Application Number
212040
Product Number
1
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
2021-03-26
Regulatory Status
RX
Drug Name
ERYTHROMYCIN LACTOBIONATE
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2024-11-19
Active Ingredient
ERYTHROMYCIN LACTOBIONATE
Application Number
216761
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2024-11-19
Regulatory Status
RX
Drug Name
ESMOLOL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2019-08-14
Active Ingredient
ESMOLOL HYDROCHLORIDE
Application Number
208538
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2019-08-14
Regulatory Status
RX
Drug Name
ESOMEPRAZOLE SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE/VIAL
Approval Date
2020-04-01
Active Ingredient
ESOMEPRAZOLE SODIUM
Application Number
203349
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE/VIAL
Approval Date
2020-04-01
Regulatory Status
RX
Drug Name
ESOMEPRAZOLE SODIUM
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE/VIAL
Approval Date
2020-04-01
Active Ingredient
ESOMEPRAZOLE SODIUM
Application Number
203349
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE/VIAL
Approval Date
2020-04-01
Regulatory Status
RX
Drug Name
ETOMIDATE
Product Number
1
Dosage Form
-
Strength
2MG/ML
Approval Date
2017-04-18
Active Ingredient
ETOMIDATE
Application Number
209058
Product Number
1
Dosage Form
-
Strength
2MG/ML
Approval Date
2017-04-18
Regulatory Status
RX
Drug Name
FLUOROURACIL
Product Number
1
Dosage Form
-
Strength
500MG/10ML (50MG/ML)
Approval Date
2017-10-27
Active Ingredient
FLUOROURACIL
Application Number
210123
Product Number
1
Dosage Form
-
Strength
500MG/10ML (50MG/ML)
Approval Date
2017-10-27
Regulatory Status
RX
Drug Name
FLUOROURACIL
Product Number
2
Dosage Form
-
Strength
1GM/20ML (50MG/ML)
Approval Date
2017-10-27
Active Ingredient
FLUOROURACIL
Application Number
210123
Product Number
2
Dosage Form
-
Strength
1GM/20ML (50MG/ML)
Approval Date
2017-10-27
Regulatory Status
RX
Drug Name
FLUOROURACIL
Product Number
1
Dosage Form
-
Strength
2.5GM/50ML (50MG/ML)
Approval Date
2017-12-26
Active Ingredient
FLUOROURACIL
Application Number
210124
Product Number
1
Dosage Form
-
Strength
2.5GM/50ML (50MG/ML)
Approval Date
2017-12-26
Regulatory Status
RX
Drug Name
FLUOROURACIL
Product Number
2
Dosage Form
-
Strength
5GM/100ML (50MG/ML)
Approval Date
2017-12-26
Active Ingredient
FLUOROURACIL
Application Number
210124
Product Number
2
Dosage Form
-
Strength
5GM/100ML (50MG/ML)
Approval Date
2017-12-26
Regulatory Status
RX
Drug Name
FLUPHENAZINE DECANOATE
Product Number
1
Dosage Form
-
Strength
25MG/ML
Approval Date
2023-03-30
Active Ingredient
FLUPHENAZINE DECANOATE
Application Number
215509
Product Number
1
Dosage Form
-
Strength
25MG/ML
Approval Date
2023-03-30
Regulatory Status
RX
Drug Name
FOMEPIZOLE
Product Number
1
Dosage Form
-
Strength
1.5GM/1.5ML (1GM/ML)
Approval Date
2023-07-06
Active Ingredient
FOMEPIZOLE
Application Number
216791
Product Number
1
Dosage Form
-
Strength
1.5GM/1.5ML (1GM/ML)
Approval Date
2023-07-06
Regulatory Status
RX
Drug Name
FOSCARNET SODIUM
Product Number
1
Dosage Form
-
Strength
6GM/250ML (24MG/ML)
Approval Date
2021-04-21
Active Ingredient
FOSCARNET SODIUM
Application Number
213001
Product Number
1
Dosage Form
-
Strength
6GM/250ML (24MG/ML)
Approval Date
2021-04-21
Regulatory Status
RX
Drug Name
FOSPHENYTOIN SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 50MG PHENYTOIN NA/ML
Approval Date
2023-10-13
Active Ingredient
FOSPHENYTOIN SODIUM
Application Number
214926
Product Number
1
Dosage Form
-
Strength
EQ 50MG PHENYTOIN NA/ML
Approval Date
2023-10-13
Regulatory Status
RX
Drug Name
FUROSEMIDE
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2020-07-01
Active Ingredient
FUROSEMIDE
Application Number
213902
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2020-07-01
Regulatory Status
RX
Drug Name
GANIRELIX ACETATE
Product Number
1
Dosage Form
-
Strength
250MCG/0.5ML
Approval Date
2023-02-28
Active Ingredient
GANIRELIX ACETATE
Application Number
215658
Product Number
1
Dosage Form
-
Strength
250MCG/0.5ML
Approval Date
2023-02-28
Regulatory Status
RX
Drug Name
GEMCITABINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 200MG BASE/VIAL
Approval Date
2016-01-05
Active Ingredient
GEMCITABINE HYDROCHLORIDE
Application Number
204520
Product Number
1
Dosage Form
-
Strength
EQ 200MG BASE/VIAL
Approval Date
2016-01-05
Regulatory Status
RX
Drug Name
GEMCITABINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
2016-01-05
Active Ingredient
GEMCITABINE HYDROCHLORIDE
Application Number
204520
Product Number
2
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
2016-01-05
Regulatory Status
RX
Drug Name
GLYCOPYRROLATE
Product Number
1
Dosage Form
-
Strength
0.2MG/ML
Approval Date
2019-09-30
Active Ingredient
GLYCOPYRROLATE
Application Number
212612
Product Number
1
Dosage Form
-
Strength
0.2MG/ML
Approval Date
2019-09-30
Regulatory Status
RX
Drug Name
HALOPERIDOL
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/ML
Approval Date
2004-08-25
Active Ingredient
HALOPERIDOL LACTATE
Application Number
76774
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/ML
Approval Date
2004-08-25
Regulatory Status
Discontinued
Drug Name
HALOPERIDOL DECANOATE
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/ML
Approval Date
2017-05-12
Active Ingredient
HALOPERIDOL DECANOATE
Application Number
205241
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/ML
Approval Date
2017-05-12
Regulatory Status
RX
Drug Name
HALOPERIDOL DECANOATE
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE/ML
Approval Date
2017-05-12
Active Ingredient
HALOPERIDOL DECANOATE
Application Number
205241
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE/ML
Approval Date
2017-05-12
Regulatory Status
RX
Drug Name
HEPARIN SODIUM
Product Number
1
Dosage Form
-
Strength
5,000 UNITS/ML
Approval Date
2017-02-06
Active Ingredient
HEPARIN SODIUM
Application Number
205323
Product Number
1
Dosage Form
-
Strength
5,000 UNITS/ML
Approval Date
2017-02-06
Regulatory Status
RX
Drug Name
HEPARIN SODIUM
Product Number
2
Dosage Form
-
Strength
1,000 UNITS/ML
Approval Date
2019-11-18
Active Ingredient
HEPARIN SODIUM
Application Number
205323
Product Number
2
Dosage Form
-
Strength
1,000 UNITS/ML
Approval Date
2019-11-18
Regulatory Status
RX
Drug Name
IRINOTECAN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
40MG/2ML (20MG/ML)
Approval Date
2019-11-18
Active Ingredient
IRINOTECAN HYDROCHLORIDE
Application Number
212993
Product Number
1
Dosage Form
-
Strength
40MG/2ML (20MG/ML)
Approval Date
2019-11-18
Regulatory Status
RX
Drug Name
IRINOTECAN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
100MG/5ML (20MG/ML)
Approval Date
2019-11-18
Active Ingredient
IRINOTECAN HYDROCHLORIDE
Application Number
212993
Product Number
2
Dosage Form
-
Strength
100MG/5ML (20MG/ML)
Approval Date
2019-11-18
Regulatory Status
RX
Drug Name
ISOPROTERENOL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
0.2MG/ML
Approval Date
2024-10-03
Active Ingredient
ISOPROTERENOL HYDROCHLORIDE
Application Number
217648
Product Number
1
Dosage Form
-
Strength
0.2MG/ML
Approval Date
2024-10-03
Regulatory Status
RX
Drug Name
KETAMINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/ML
Approval Date
2023-01-24
Active Ingredient
KETAMINE HYDROCHLORIDE
Application Number
216809
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/ML
Approval Date
2023-01-24
Regulatory Status
RX
Drug Name
KETAMINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE/ML
Approval Date
2023-01-24
Active Ingredient
KETAMINE HYDROCHLORIDE
Application Number
216809
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE/ML
Approval Date
2023-01-24
Regulatory Status
RX
Drug Name
KETAMINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE/ML
Approval Date
2023-01-24
Active Ingredient
KETAMINE HYDROCHLORIDE
Application Number
216809
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE/ML
Approval Date
2023-01-24
Regulatory Status
RX
Drug Name
KETOROLAC TROMETHAMINE
Product Number
1
Dosage Form
-
Strength
15MG/ML
Approval Date
2004-07-27
Active Ingredient
KETOROLAC TROMETHAMINE
Application Number
76722
Product Number
1
Dosage Form
-
Strength
15MG/ML
Approval Date
2004-07-27
Regulatory Status
Discontinued
Drug Name
KETOROLAC TROMETHAMINE
Product Number
2
Dosage Form
-
Strength
30MG/ML
Approval Date
2004-07-27
Active Ingredient
KETOROLAC TROMETHAMINE
Application Number
76722
Product Number
2
Dosage Form
-
Strength
30MG/ML
Approval Date
2004-07-27
Regulatory Status
Discontinued
Drug Name
KETOROLAC TROMETHAMINE
Product Number
3
Dosage Form
-
Strength
60MG/2ML
Approval Date
-
Active Ingredient
KETOROLAC TROMETHAMINE
Application Number
76722
Product Number
3
Dosage Form
-
Strength
60MG/2ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
KETOROLAC TROMETHAMINE
Product Number
1
Dosage Form
-
Strength
15MG/ML
Approval Date
2016-11-01
Active Ingredient
KETOROLAC TROMETHAMINE
Application Number
204216
Product Number
1
Dosage Form
-
Strength
15MG/ML
Approval Date
2016-11-01
Regulatory Status
RX
Drug Name
KETOROLAC TROMETHAMINE
Product Number
2
Dosage Form
-
Strength
30MG/ML
Approval Date
2016-11-01
Active Ingredient
KETOROLAC TROMETHAMINE
Application Number
204216
Product Number
2
Dosage Form
-
Strength
30MG/ML
Approval Date
2016-11-01
Regulatory Status
RX
Drug Name
LABETALOL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
5MG/ML
Approval Date
2012-04-03
Active Ingredient
LABETALOL HYDROCHLORIDE
Application Number
90699
Product Number
1
Dosage Form
-
Strength
5MG/ML
Approval Date
2012-04-03
Regulatory Status
RX
Drug Name
LACOSAMIDE
Product Number
1
Dosage Form
-
Strength
200MG/20ML (10MG/ML)
Approval Date
2022-09-19
Active Ingredient
LACOSAMIDE
Application Number
215628
Product Number
1
Dosage Form
-
Strength
200MG/20ML (10MG/ML)
Approval Date
2022-09-19
Regulatory Status
RX
Drug Name
LATANOPROST
Product Number
1
Dosage Form
-
Strength
0.005%
Approval Date
2024-11-26
Active Ingredient
LATANOPROST
Application Number
218257
Product Number
1
Dosage Form
-
Strength
0.005%
Approval Date
2024-11-26
Regulatory Status
RX
Drug Name
LATANOPROSTENE BUNOD
Product Number
1
Dosage Form
-
Strength
0.024%
Approval Date
2025-04-29
Active Ingredient
LATANOPROSTENE BUNOD
Application Number
217387
Product Number
1
Dosage Form
-
Strength
0.024%
Approval Date
2025-04-29
Regulatory Status
RX
Drug Name
LEUCOVORIN CALCIUM
Product Number
1
Dosage Form
-
Strength
EQ 350MG BASE/VIAL
Approval Date
2025-11-12
Active Ingredient
LEUCOVORIN CALCIUM
Application Number
218200
Product Number
1
Dosage Form
-
Strength
EQ 350MG BASE/VIAL
Approval Date
2025-11-12
Regulatory Status
RX
Drug Name
LEVETIRACETAM IN SODIUM CHLORIDE
Product Number
1
Dosage Form
-
Strength
500MG/100ML (5MG/ML)
Approval Date
2017-10-25
Active Ingredient
LEVETIRACETAM
Application Number
206880
Product Number
1
Dosage Form
-
Strength
500MG/100ML (5MG/ML)
Approval Date
2017-10-25
Regulatory Status
RX
Drug Name
LEVETIRACETAM IN SODIUM CHLORIDE
Product Number
2
Dosage Form
-
Strength
1GM/100ML (10MG/ML)
Approval Date
2017-10-25
Active Ingredient
LEVETIRACETAM
Application Number
206880
Product Number
2
Dosage Form
-
Strength
1GM/100ML (10MG/ML)
Approval Date
2017-10-25
Regulatory Status
RX
Drug Name
LEVETIRACETAM IN SODIUM CHLORIDE
Product Number
3
Dosage Form
-
Strength
1.5GM/100ML (15MG/ML)
Approval Date
2017-10-25
Active Ingredient
LEVETIRACETAM
Application Number
206880
Product Number
3
Dosage Form
-
Strength
1.5GM/100ML (15MG/ML)
Approval Date
2017-10-25
Regulatory Status
RX
Drug Name
LEVOFLOXACIN
Product Number
1
Dosage Form
-
Strength
EQ 500MG/20ML (EQ 25MG/ML)
Approval Date
2020-04-22
Active Ingredient
LEVOFLOXACIN
Application Number
205540
Product Number
1
Dosage Form
-
Strength
EQ 500MG/20ML (EQ 25MG/ML)
Approval Date
2020-04-22
Regulatory Status
RX
Drug Name
LEVOFLOXACIN
Product Number
2
Dosage Form
-
Strength
EQ 750MG/30ML (EQ 25MG/ML)
Approval Date
2020-04-22
Active Ingredient
LEVOFLOXACIN
Application Number
205540
Product Number
2
Dosage Form
-
Strength
EQ 750MG/30ML (EQ 25MG/ML)
Approval Date
2020-04-22
Regulatory Status
RX
Drug Name
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Product Number
1
Dosage Form
-
Strength
EQ 250MG/50ML (EQ 5MG/ML)
Approval Date
2020-12-30
Active Ingredient
LEVOFLOXACIN
Application Number
206908
Product Number
1
Dosage Form
-
Strength
EQ 250MG/50ML (EQ 5MG/ML)
Approval Date
2020-12-30
Regulatory Status
RX
Drug Name
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Product Number
2
Dosage Form
-
Strength
EQ 500MG/100ML (EQ 5MG/ML)
Approval Date
2020-12-30
Active Ingredient
LEVOFLOXACIN
Application Number
206908
Product Number
2
Dosage Form
-
Strength
EQ 500MG/100ML (EQ 5MG/ML)
Approval Date
2020-12-30
Regulatory Status
RX
Drug Name
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Product Number
3
Dosage Form
-
Strength
EQ 750MG/150ML (EQ 5MG/ML)
Approval Date
2020-12-30
Active Ingredient
LEVOFLOXACIN
Application Number
206908
Product Number
3
Dosage Form
-
Strength
EQ 750MG/150ML (EQ 5MG/ML)
Approval Date
2020-12-30
Regulatory Status
RX
Drug Name
LEVOLEUCOVORIN CALCIUM
Product Number
1
Dosage Form
-
Strength
EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)
Approval Date
2018-09-14
Active Ingredient
LEVOLEUCOVORIN CALCIUM
Application Number
210892
Product Number
1
Dosage Form
-
Strength
EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)
Approval Date
2018-09-14
Regulatory Status
RX
Drug Name
LEVOLEUCOVORIN CALCIUM
Product Number
2
Dosage Form
-
Strength
EQ 250MG BASE/25ML (EQ 10MG BASE/ML)
Approval Date
2018-09-14
Active Ingredient
LEVOLEUCOVORIN CALCIUM
Application Number
210892
Product Number
2
Dosage Form
-
Strength
EQ 250MG BASE/25ML (EQ 10MG BASE/ML)
Approval Date
2018-09-14
Regulatory Status
RX
Drug Name
LINCOMYCIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 300MG BASE/ML
Approval Date
2022-09-26
Active Ingredient
LINCOMYCIN HYDROCHLORIDE
Application Number
215657
Product Number
1
Dosage Form
-
Strength
EQ 300MG BASE/ML
Approval Date
2022-09-26
Regulatory Status
RX
Drug Name
MAGNESIUM SULFATE IN PLASTIC CONTAINER
Product Number
1
Dosage Form
-
Strength
2GM/50ML (40MG/ML)
Approval Date
2020-07-10
Active Ingredient
MAGNESIUM SULFATE
Application Number
213917
Product Number
1
Dosage Form
-
Strength
2GM/50ML (40MG/ML)
Approval Date
2020-07-10
Regulatory Status
RX
Drug Name
MAGNESIUM SULFATE IN PLASTIC CONTAINER
Product Number
2
Dosage Form
-
Strength
4GM/100ML (40MG/ML)
Approval Date
2020-07-10
Active Ingredient
MAGNESIUM SULFATE
Application Number
213917
Product Number
2
Dosage Form
-
Strength
4GM/100ML (40MG/ML)
Approval Date
2020-07-10
Regulatory Status
RX
Drug Name
MELPHALAN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/VIAL
Approval Date
2019-05-28
Active Ingredient
MELPHALAN HYDROCHLORIDE
Application Number
209826
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/VIAL
Approval Date
2019-05-28
Regulatory Status
RX
Drug Name
MEROPENEM
Product Number
1
Dosage Form
-
Strength
500MG/VIAL
Approval Date
2016-06-08
Active Ingredient
MEROPENEM
Application Number
206141
Product Number
1
Dosage Form
-
Strength
500MG/VIAL
Approval Date
2016-06-08
Regulatory Status
RX
Drug Name
MEROPENEM
Product Number
2
Dosage Form
-
Strength
1GM/VIAL
Approval Date
2016-06-08
Active Ingredient
MEROPENEM
Application Number
206141
Product Number
2
Dosage Form
-
Strength
1GM/VIAL
Approval Date
2016-06-08
Regulatory Status
RX
Drug Name
MESNA
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2017-12-18
Active Ingredient
MESNA
Application Number
206992
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2017-12-18
Regulatory Status
RX
Drug Name
METHOCARBAMOL
Product Number
1
Dosage Form
-
Strength
1GM/10ML (100MG/ML)
Approval Date
2018-10-26
Active Ingredient
METHOCARBAMOL
Application Number
211504
Product Number
1
Dosage Form
-
Strength
1GM/10ML (100MG/ML)
Approval Date
2018-10-26
Regulatory Status
RX
Drug Name
METOPROLOL TARTRATE
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2014-08-27
Active Ingredient
METOPROLOL TARTRATE
Application Number
204205
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2014-08-27
Regulatory Status
RX
Drug Name
METRONIDAZOLE IN PLASTIC CONTAINER
Product Number
1
Dosage Form
-
Strength
500MG/100ML
Approval Date
2020-08-03
Active Ingredient
METRONIDAZOLE
Application Number
212435
Product Number
1
Dosage Form
-
Strength
500MG/100ML
Approval Date
2020-08-03
Regulatory Status
RX
Drug Name
MIDAZOLAM HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/ML
Approval Date
2012-02-29
Active Ingredient
MIDAZOLAM HYDROCHLORIDE
Application Number
90696
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/ML
Approval Date
2012-02-29
Regulatory Status
RX
Drug Name
MIDAZOLAM HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/ML
Approval Date
2012-01-25
Active Ingredient
MIDAZOLAM HYDROCHLORIDE
Application Number
90850
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/ML
Approval Date
2012-01-25
Regulatory Status
RX
Drug Name
MIDAZOLAM IN 0.9% SODIUM CHLORIDE
Product Number
1
Dosage Form
-
Strength
50MG/50ML (1MG/ML)
Approval Date
2024-08-12
Active Ingredient
MIDAZOLAM
Application Number
218993
Product Number
1
Dosage Form
-
Strength
50MG/50ML (1MG/ML)
Approval Date
2024-08-12
Regulatory Status
RX
Drug Name
MIDAZOLAM IN 0.9% SODIUM CHLORIDE
Product Number
2
Dosage Form
-
Strength
100MG/100ML (1MG/ML)
Approval Date
2024-08-12
Active Ingredient
MIDAZOLAM
Application Number
218993
Product Number
2
Dosage Form
-
Strength
100MG/100ML (1MG/ML)
Approval Date
2024-08-12
Regulatory Status
RX
Drug Name
MILRINONE LACTATE
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/ML
Approval Date
2006-10-31
Active Ingredient
MILRINONE LACTATE
Application Number
77190
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/ML
Approval Date
2006-10-31
Regulatory Status
Discontinued
Drug Name
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)
Approval Date
2020-07-16
Active Ingredient
MILRINONE LACTATE
Application Number
213585
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)
Approval Date
2020-07-16
Regulatory Status
RX
Drug Name
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)
Approval Date
2020-07-16
Active Ingredient
MILRINONE LACTATE
Application Number
213585
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)
Approval Date
2020-07-16
Regulatory Status
RX
Drug Name
MITOMYCIN
Product Number
1
Dosage Form
-
Strength
5MG/VIAL
Approval Date
2021-10-20
Active Ingredient
MITOMYCIN
Application Number
215687
Product Number
1
Dosage Form
-
Strength
5MG/VIAL
Approval Date
2021-10-20
Regulatory Status
RX
Drug Name
MITOMYCIN
Product Number
2
Dosage Form
-
Strength
20MG/VIAL
Approval Date
2021-10-20
Active Ingredient
MITOMYCIN
Application Number
215687
Product Number
2
Dosage Form
-
Strength
20MG/VIAL
Approval Date
2021-10-20
Regulatory Status
RX
Drug Name
MITOMYCIN
Product Number
1
Dosage Form
-
Strength
40MG/VIAL
Approval Date
2022-11-22
Active Ingredient
MITOMYCIN
Application Number
216648
Product Number
1
Dosage Form
-
Strength
40MG/VIAL
Approval Date
2022-11-22
Regulatory Status
RX
Drug Name
MOXIFLOXACIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 0.5% BASE
Approval Date
2020-03-30
Active Ingredient
MOXIFLOXACIN HYDROCHLORIDE
Application Number
208778
Product Number
1
Dosage Form
-
Strength
EQ 0.5% BASE
Approval Date
2020-03-30
Regulatory Status
RX
Drug Name
NELARABINE
Product Number
1
Dosage Form
-
Strength
250MG/50ML (5MG/ML)
Approval Date
2024-01-03
Active Ingredient
NELARABINE
Application Number
212605
Product Number
1
Dosage Form
-
Strength
250MG/50ML (5MG/ML)
Approval Date
2024-01-03
Regulatory Status
RX
Drug Name
NEOSTIGMINE METHYLSULFATE
Product Number
1
Dosage Form
-
Strength
5MG/10ML (0.5MG/ML)
Approval Date
2019-10-16
Active Ingredient
NEOSTIGMINE METHYLSULFATE
Application Number
212968
Product Number
1
Dosage Form
-
Strength
5MG/10ML (0.5MG/ML)
Approval Date
2019-10-16
Regulatory Status
RX
Drug Name
NEOSTIGMINE METHYLSULFATE
Product Number
2
Dosage Form
-
Strength
10MG/10ML (1MG/ML)
Approval Date
2019-10-16
Active Ingredient
NEOSTIGMINE METHYLSULFATE
Application Number
212968
Product Number
2
Dosage Form
-
Strength
10MG/10ML (1MG/ML)
Approval Date
2019-10-16
Regulatory Status
RX
Drug Name
NETARSUDIL MESYLATE
Product Number
1
Dosage Form
-
Strength
0.02%
Approval Date
-
Active Ingredient
NETARSUDIL
Application Number
216855
Product Number
1
Dosage Form
-
Strength
0.02%
Approval Date
-
Regulatory Status
Unclassified
Drug Name
NOREPINEPHRINE BITARTRATE
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/ML
Approval Date
2021-05-06
Active Ingredient
NOREPINEPHRINE BITARTRATE
Application Number
214323
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/ML
Approval Date
2021-05-06
Regulatory Status
RX
Drug Name
OCTREOTIDE ACETATE
Product Number
1
Dosage Form
-
Strength
EQ 0.2MG BASE/ML
Approval Date
2023-06-13
Active Ingredient
OCTREOTIDE ACETATE
Application Number
216807
Product Number
1
Dosage Form
-
Strength
EQ 0.2MG BASE/ML
Approval Date
2023-06-13
Regulatory Status
RX
Drug Name
OCTREOTIDE ACETATE
Product Number
2
Dosage Form
-
Strength
EQ 1MG BASE/ML
Approval Date
2023-06-13
Active Ingredient
OCTREOTIDE ACETATE
Application Number
216807
Product Number
2
Dosage Form
-
Strength
EQ 1MG BASE/ML
Approval Date
2023-06-13
Regulatory Status
RX
Drug Name
OCTREOTIDE ACETATE
Product Number
1
Dosage Form
-
Strength
EQ 0.5MG BASE/ML
Approval Date
2023-06-22
Active Ingredient
OCTREOTIDE ACETATE
Application Number
216839
Product Number
1
Dosage Form
-
Strength
EQ 0.5MG BASE/ML
Approval Date
2023-06-22
Regulatory Status
RX
Drug Name
OCTREOTIDE ACETATE
Product Number
2
Dosage Form
-
Strength
EQ 0.1MG BASE/ML
Approval Date
2023-06-22
Active Ingredient
OCTREOTIDE ACETATE
Application Number
216839
Product Number
2
Dosage Form
-
Strength
EQ 0.1MG BASE/ML
Approval Date
2023-06-22
Regulatory Status
RX
Drug Name
OLOPATADINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 0.1% BASE
Approval Date
2019-08-02
Active Ingredient
OLOPATADINE HYDROCHLORIDE
Application Number
209619
Product Number
1
Dosage Form
-
Strength
EQ 0.1% BASE
Approval Date
2019-08-02
Regulatory Status
OTC
Drug Name
OLOPATADINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 0.2% BASE
Approval Date
2020-05-20
Active Ingredient
OLOPATADINE HYDROCHLORIDE
Application Number
209752
Product Number
1
Dosage Form
-
Strength
EQ 0.2% BASE
Approval Date
2020-05-20
Regulatory Status
OTC
Drug Name
OLOPATADINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 0.7% BASE
Approval Date
2026-01-06
Active Ingredient
OLOPATADINE HYDROCHLORIDE
Application Number
213514
Product Number
1
Dosage Form
-
Strength
EQ 0.7% BASE
Approval Date
2026-01-06
Regulatory Status
OTC
Drug Name
ONDANSETRON HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE/ML
Approval Date
2009-09-25
Active Ingredient
ONDANSETRON HYDROCHLORIDE
Application Number
79224
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE/ML
Approval Date
2009-09-25
Regulatory Status
RX
Drug Name
ONDANSETRON HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE/ML
Approval Date
2012-06-15
Active Ingredient
ONDANSETRON HYDROCHLORIDE
Application Number
90648
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE/ML
Approval Date
2012-06-15
Regulatory Status
RX
Drug Name
OXALIPLATIN
Product Number
1
Dosage Form
-
Strength
50MG/10ML (5MG/ML)
Approval Date
2017-02-10
Active Ingredient
OXALIPLATIN
Application Number
207325
Product Number
1
Dosage Form
-
Strength
50MG/10ML (5MG/ML)
Approval Date
2017-02-10
Regulatory Status
RX
Drug Name
OXALIPLATIN
Product Number
2
Dosage Form
-
Strength
100MG/20ML (5MG/ML)
Approval Date
2017-02-10
Active Ingredient
OXALIPLATIN
Application Number
207325
Product Number
2
Dosage Form
-
Strength
100MG/20ML (5MG/ML)
Approval Date
2017-02-10
Regulatory Status
RX
Drug Name
OXALIPLATIN
Product Number
3
Dosage Form
-
Strength
200MG/40ML (5MG/ML)
Approval Date
2017-10-18
Active Ingredient
OXALIPLATIN
Application Number
207325
Product Number
3
Dosage Form
-
Strength
200MG/40ML (5MG/ML)
Approval Date
2017-10-18
Regulatory Status
Discontinued
Drug Name
OXALIPLATIN
Product Number
1
Dosage Form
-
Strength
50MG/VIAL
Approval Date
2017-05-23
Active Ingredient
OXALIPLATIN
Application Number
207385
Product Number
1
Dosage Form
-
Strength
50MG/VIAL
Approval Date
2017-05-23
Regulatory Status
RX
Drug Name
OXALIPLATIN
Product Number
2
Dosage Form
-
Strength
100MG/VIAL
Approval Date
2017-05-23
Active Ingredient
OXALIPLATIN
Application Number
207385
Product Number
2
Dosage Form
-
Strength
100MG/VIAL
Approval Date
2017-05-23
Regulatory Status
RX
Drug Name
PACLITAXEL
Product Number
1
Dosage Form
-
Strength
6MG/ML
Approval Date
2016-08-23
Active Ingredient
PACLITAXEL
Application Number
207326
Product Number
1
Dosage Form
-
Strength
6MG/ML
Approval Date
2016-08-23
Regulatory Status
RX
Drug Name
PANTOPRAZOLE SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 40MG BASE/VIAL
Approval Date
2022-05-18
Active Ingredient
PANTOPRAZOLE SODIUM
Application Number
204400
Product Number
1
Dosage Form
-
Strength
EQ 40MG BASE/VIAL
Approval Date
2022-05-18
Regulatory Status
RX
Drug Name
PHENYLEPHRINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
50MG/5ML (10MG/ML)
Approval Date
2020-06-05
Active Ingredient
PHENYLEPHRINE HYDROCHLORIDE
Application Number
211920
Product Number
1
Dosage Form
-
Strength
50MG/5ML (10MG/ML)
Approval Date
2020-06-05
Regulatory Status
RX
Drug Name
PHENYLEPHRINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
100MG/10ML (10MG/ML)
Approval Date
2020-06-05
Active Ingredient
PHENYLEPHRINE HYDROCHLORIDE
Application Number
211920
Product Number
2
Dosage Form
-
Strength
100MG/10ML (10MG/ML)
Approval Date
2020-06-05
Regulatory Status
RX
Drug Name
PHENYLEPHRINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
10MG/ML (10MG/ML)
Approval Date
2021-04-08
Active Ingredient
PHENYLEPHRINE HYDROCHLORIDE
Application Number
211920
Product Number
3
Dosage Form
-
Strength
10MG/ML (10MG/ML)
Approval Date
2021-04-08
Regulatory Status
RX
Drug Name
PHENYLEPHRINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
2.5%
Approval Date
2024-12-18
Active Ingredient
PHENYLEPHRINE HYDROCHLORIDE
Application Number
218129
Product Number
1
Dosage Form
-
Strength
2.5%
Approval Date
2024-12-18
Regulatory Status
RX
Drug Name
PHENYLEPHRINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
10%
Approval Date
2024-12-18
Active Ingredient
PHENYLEPHRINE HYDROCHLORIDE
Application Number
218129
Product Number
2
Dosage Form
-
Strength
10%
Approval Date
2024-12-18
Regulatory Status
RX
Drug Name
PHYTONADIONE
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2024-12-10
Active Ingredient
PHYTONADIONE
Application Number
217386
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2024-12-10
Regulatory Status
RX
Drug Name
PLERIXAFOR
Product Number
1
Dosage Form
-
Strength
24MG/1.2ML (20MG/ML)
Approval Date
2024-05-03
Active Ingredient
PLERIXAFOR
Application Number
206644
Product Number
1
Dosage Form
-
Strength
24MG/1.2ML (20MG/ML)
Approval Date
2024-05-03
Regulatory Status
RX
Drug Name
POLYMYXIN B SULFATE
Product Number
1
Dosage Form
-
Strength
EQ 500,000 UNITS BASE/VIAL
Approval Date
2016-04-14
Active Ingredient
POLYMYXIN B SULFATE
Application Number
207322
Product Number
1
Dosage Form
-
Strength
EQ 500,000 UNITS BASE/VIAL
Approval Date
2016-04-14
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
217553
Product Number
1
Dosage Form
-
Strength
300MG/16.7ML (18MG/ML)
Approval Date
2023-12-26
Regulatory Status
RX
Drug Name
PROCAINAMIDE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2024-07-22
Active Ingredient
PROCAINAMIDE HYDROCHLORIDE
Application Number
218135
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2024-07-22
Regulatory Status
RX
Drug Name
PROCAINAMIDE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
500MG/ML
Approval Date
2024-07-22
Active Ingredient
PROCAINAMIDE HYDROCHLORIDE
Application Number
218135
Product Number
2
Dosage Form
-
Strength
500MG/ML
Approval Date
2024-07-22
Regulatory Status
RX
Drug Name
PROCHLORPERAZINE EDISYLATE
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/ML
Approval Date
2021-09-22
Active Ingredient
PROCHLORPERAZINE EDISYLATE
Application Number
214107
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/ML
Approval Date
2021-09-22
Regulatory Status
RX
Drug Name
REGADENOSON
Product Number
1
Dosage Form
-
Strength
0.4MG/5ML (0.08MG/ML)
Approval Date
2022-07-12
Active Ingredient
REGADENOSON
Application Number
207320
Product Number
1
Dosage Form
-
Strength
0.4MG/5ML (0.08MG/ML)
Approval Date
2022-07-12
Regulatory Status
RX
Drug Name
ROCURONIUM BROMIDE
Product Number
1
Dosage Form
-
Strength
50MG/5ML (10MG/ML)
Approval Date
2018-04-04
Active Ingredient
ROCURONIUM BROMIDE
Application Number
205656
Product Number
1
Dosage Form
-
Strength
50MG/5ML (10MG/ML)
Approval Date
2018-04-04
Regulatory Status
RX
Drug Name
ROCURONIUM BROMIDE
Product Number
2
Dosage Form
-
Strength
100MG/10ML (10MG/ML)
Approval Date
2018-04-04
Active Ingredient
ROCURONIUM BROMIDE
Application Number
205656
Product Number
2
Dosage Form
-
Strength
100MG/10ML (10MG/ML)
Approval Date
2018-04-04
Regulatory Status
RX
Drug Name
ROPIVACAINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
200MG/100ML (2MG/ML)
Approval Date
2022-08-18
Active Ingredient
ROPIVACAINE HYDROCHLORIDE
Application Number
210102
Product Number
1
Dosage Form
-
Strength
200MG/100ML (2MG/ML)
Approval Date
2022-08-18
Regulatory Status
RX
Drug Name
ROPIVACAINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
400MG/200ML (2MG/ML)
Approval Date
2022-08-18
Active Ingredient
ROPIVACAINE HYDROCHLORIDE
Application Number
210102
Product Number
2
Dosage Form
-
Strength
400MG/200ML (2MG/ML)
Approval Date
2022-08-18
Regulatory Status
RX
Drug Name
SELENIOUS ACID
Product Number
1
Dosage Form
-
Strength
EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML)
Approval Date
2025-07-08
Active Ingredient
SELENIOUS ACID
Application Number
219629
Product Number
1
Dosage Form
-
Strength
EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML)
Approval Date
2025-07-08
Regulatory Status
RX
Drug Name
SUCCINYLCHOLINE CHLORIDE
Product Number
1
Dosage Form
-
Strength
20MG/ML
Approval Date
2020-06-16
Active Ingredient
SUCCINYLCHOLINE CHLORIDE
Application Number
214246
Product Number
1
Dosage Form
-
Strength
20MG/ML
Approval Date
2020-06-16
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
214364
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
214364
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE/5ML (EQ 100MG BASE/ML)
Approval Date
2026-07-28
Regulatory Status
RX
Drug Name
TEMSIROLIMUS
Product Number
1
Dosage Form
-
Strength
25MG/ML (25MG/ML)
Approval Date
2019-08-16
Active Ingredient
TEMSIROLIMUS
Application Number
207383
Product Number
1
Dosage Form
-
Strength
25MG/ML (25MG/ML)
Approval Date
2019-08-16
Regulatory Status
RX
Drug Name
THIAMINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2025-02-24
Active Ingredient
THIAMINE HYDROCHLORIDE
Application Number
217800
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2025-02-24
Regulatory Status
RX
Drug Name
THIOTEPA
Product Number
1
Dosage Form
-
Strength
15MG/VIAL
Approval Date
2021-03-08
Active Ingredient
THIOTEPA
Application Number
214222
Product Number
1
Dosage Form
-
Strength
15MG/VIAL
Approval Date
2021-03-08
Regulatory Status
RX
Drug Name
THIOTEPA
Product Number
2
Dosage Form
-
Strength
100MG/VIAL
Approval Date
2022-01-03
Active Ingredient
THIOTEPA
Application Number
214222
Product Number
2
Dosage Form
-
Strength
100MG/VIAL
Approval Date
2022-01-03
Regulatory Status
RX
Drug Name
TIMOLOL MALEATE
Product Number
1
Dosage Form
-
Strength
EQ 0.25% BASE
Approval Date
2022-06-24
Active Ingredient
TIMOLOL MALEATE
Application Number
214645
Product Number
1
Dosage Form
-
Strength
EQ 0.25% BASE
Approval Date
2022-06-24
Regulatory Status
RX
Drug Name
TIMOLOL MALEATE
Product Number
2
Dosage Form
-
Strength
EQ 0.5% BASE
Approval Date
2023-02-14
Active Ingredient
TIMOLOL MALEATE
Application Number
214645
Product Number
2
Dosage Form
-
Strength
EQ 0.5% BASE
Approval Date
2023-02-14
Regulatory Status
RX
Drug Name
TIROFIBAN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)
Approval Date
2021-04-08
Active Ingredient
TIROFIBAN HYDROCHLORIDE
Application Number
206888
Product Number
1
Dosage Form
-
Strength
EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)
Approval Date
2021-04-08
Regulatory Status
RX
Drug Name
TOBRAMYCIN
Product Number
1
Dosage Form
-
Strength
0.3%
Approval Date
2021-03-09
Active Ingredient
TOBRAMYCIN
Application Number
212628
Product Number
1
Dosage Form
-
Strength
0.3%
Approval Date
2021-03-09
Regulatory Status
RX
Drug Name
TOBRAMYCIN SULFATE
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/ML
Approval Date
2021-02-11
Active Ingredient
TOBRAMYCIN SULFATE
Application Number
209621
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/ML
Approval Date
2021-02-11
Regulatory Status
RX
Drug Name
TOBRAMYCIN SULFATE
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE/ML
Approval Date
2021-02-11
Active Ingredient
TOBRAMYCIN SULFATE
Application Number
209621
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE/ML
Approval Date
2021-02-11
Regulatory Status
RX
Drug Name
TOBRAMYCIN SULFATE
Product Number
1
Dosage Form
-
Strength
EQ 1.2GM BASE/VIAL
Approval Date
2021-05-18
Active Ingredient
TOBRAMYCIN SULFATE
Application Number
211189
Product Number
1
Dosage Form
-
Strength
EQ 1.2GM BASE/VIAL
Approval Date
2021-05-18
Regulatory Status
RX
Drug Name
TOBRAMYCIN SULFATE (PHARMACY BULK)
Product Number
1
Dosage Form
-
Strength
EQ 40MG BASE/ML
Approval Date
2021-02-09
Active Ingredient
TOBRAMYCIN SULFATE
Application Number
209346
Product Number
1
Dosage Form
-
Strength
EQ 40MG BASE/ML
Approval Date
2021-02-09
Regulatory Status
RX
Drug Name
TRANEXAMIC ACID
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2017-02-13
Active Ingredient
TRANEXAMIC ACID
Application Number
207239
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2017-02-13
Regulatory Status
RX
Drug Name
TRANEXAMIC ACID
Product Number
1
Dosage Form
-
Strength
1GM/100ML (10MG/ML)
Approval Date
2024-04-16
Active Ingredient
TRANEXAMIC ACID
Application Number
218599
Product Number
1
Dosage Form
-
Strength
1GM/100ML (10MG/ML)
Approval Date
2024-04-16
Regulatory Status
RX
Drug Name
TRAVOPROST
Product Number
1
Dosage Form
-
Strength
0.004%
Approval Date
2024-07-12
Active Ingredient
TRAVOPROST
Application Number
218159
Product Number
1
Dosage Form
-
Strength
0.004%
Approval Date
2024-07-12
Regulatory Status
RX
Drug Name
VANCOMYCIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2016-01-21
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
205694
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2016-01-21
Regulatory Status
RX
Drug Name
VANCOMYCIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
2016-01-21
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
205694
Product Number
2
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
2016-01-21
Regulatory Status
RX
Drug Name
VANCOMYCIN HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 5GM BASE/VIAL
Approval Date
2023-06-06
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
205694
Product Number
3
Dosage Form
-
Strength
EQ 5GM BASE/VIAL
Approval Date
2023-06-06
Regulatory Status
RX
Drug Name
VANCOMYCIN HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
EQ 10GM BASE/VIAL
Approval Date
2023-06-06
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
205694
Product Number
4
Dosage Form
-
Strength
EQ 10GM BASE/VIAL
Approval Date
2023-06-06
Regulatory Status
RX
Drug Name
VANCOMYCIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 750MG BASE/VIAL
Approval Date
2025-03-21
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
218140
Product Number
1
Dosage Form
-
Strength
EQ 750MG BASE/VIAL
Approval Date
2025-03-21
Regulatory Status
RX
Drug Name
VANCOMYCIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 1.25GM BASE/VIAL
Approval Date
2025-03-21
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
218140
Product Number
2
Dosage Form
-
Strength
EQ 1.25GM BASE/VIAL
Approval Date
2025-03-21
Regulatory Status
RX
Drug Name
VANCOMYCIN HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 1.5GM BASE/VIAL
Approval Date
2025-03-21
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
218140
Product Number
3
Dosage Form
-
Strength
EQ 1.5GM BASE/VIAL
Approval Date
2025-03-21
Regulatory Status
RX
Drug Name
VASOPRESSIN
Product Number
1
Dosage Form
-
Strength
20UNITS/ML (20UNITS/ML)
Approval Date
2024-02-09
Active Ingredient
VASOPRESSIN
Application Number
216963
Product Number
1
Dosage Form
-
Strength
20UNITS/ML (20UNITS/ML)
Approval Date
2024-02-09
Regulatory Status
RX
Drug Name
VASOPRESSIN IN DEXTROSE 5%
Product Number
2
Dosage Form
-
Strength
40UNITS/100ML (0.4UNITS/ML)
Approval Date
2025-08-22
Active Ingredient
VASOPRESSIN
Application Number
216963
Product Number
2
Dosage Form
-
Strength
40UNITS/100ML (0.4UNITS/ML)
Approval Date
2025-08-22
Regulatory Status
RX
Drug Name
VECURONIUM BROMIDE
Product Number
1
Dosage Form
-
Strength
10MG/VIAL
Approval Date
2016-05-26
Active Ingredient
VECURONIUM BROMIDE
Application Number
205390
Product Number
1
Dosage Form
-
Strength
10MG/VIAL
Approval Date
2016-05-26
Regulatory Status
RX
Drug Name
VECURONIUM BROMIDE
Product Number
2
Dosage Form
-
Strength
20MG/VIAL
Approval Date
2016-05-26
Active Ingredient
VECURONIUM BROMIDE
Application Number
205390
Product Number
2
Dosage Form
-
Strength
20MG/VIAL
Approval Date
2016-05-26
Regulatory Status
RX
Drug Name
VERAPAMIL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
2.5MG/ML
Approval Date
2020-10-15
Active Ingredient
VERAPAMIL HYDROCHLORIDE
Application Number
214361
Product Number
1
Dosage Form
-
Strength
2.5MG/ML
Approval Date
2020-10-15
Regulatory Status
RX
Drug Name
VORICONAZOLE
Product Number
1
Dosage Form
-
Strength
200MG/VIAL
Approval Date
2020-03-31
Active Ingredient
VORICONAZOLE
Application Number
211099
Product Number
1
Dosage Form
-
Strength
200MG/VIAL
Approval Date
2020-03-31
Regulatory Status
RX
Drug Name
ZINC SULFATE
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE/5ML (EQ 5MG BASE/ML)
Approval Date
2022-05-03
Active Ingredient
ZINC SULFATE
Application Number
216249
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE/5ML (EQ 5MG BASE/ML)
Approval Date
2022-05-03
Regulatory Status
RX
Drug Name
ZINC SULFATE
Product Number
2
Dosage Form
-
Strength
EQ 30MG BASE/10ML (EQ 3MG BASE/ML)
Approval Date
2022-05-03
Active Ingredient
ZINC SULFATE
Application Number
216249
Product Number
2
Dosage Form
-
Strength
EQ 30MG BASE/10ML (EQ 3MG BASE/ML)
Approval Date
2022-05-03
Regulatory Status
RX
Drug Name
ZINC SULFATE
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE/10ML (EQ 1MG BASE/ML)
Approval Date
2023-09-01
Active Ingredient
ZINC SULFATE
Application Number
216249
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE/10ML (EQ 1MG BASE/ML)
Approval Date
2023-09-01
Regulatory Status
RX
Drug Name
ZINC SULFATE HEPTAHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID
Product Number
1
Dosage Form
-
Strength
55UG/1ML
Approval Date
-
Active Ingredient
ZINC SULFATE HEPTAHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID
Application Number
219632
Product Number
1
Dosage Form
-
Strength
55UG/1ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ZINC SULFATE HEPTAHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID
Product Number
2
Dosage Form
-
Strength
0.3MG/1ML
Approval Date
-
Active Ingredient
ZINC SULFATE HEPTAHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID
Application Number
219632
Product Number
2
Dosage Form
-
Strength
0.3MG/1ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ZINC SULFATE HEPTAHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID
Product Number
3
Dosage Form
-
Strength
60UG/1ML
Approval Date
-
Active Ingredient
ZINC SULFATE HEPTAHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID
Application Number
219632
Product Number
3
Dosage Form
-
Strength
60UG/1ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ZINC SULFATE HEPTAHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID
Product Number
4
Dosage Form
-
Strength
3MG/1ML
Approval Date
-
Active Ingredient
ZINC SULFATE HEPTAHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID
Application Number
219632
Product Number
4
Dosage Form
-
Strength
3MG/1ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ZINC SULFATE HEPTAHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID
Product Number
5
Dosage Form
-
Strength
1000UG/1ML
Approval Date
-
Active Ingredient
ZINC SULFATE HEPTAHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID
Application Number
219632
Product Number
5
Dosage Form
-
Strength
1000UG/1ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ZINC SULFATE HEPTAHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID
Product Number
6
Dosage Form
-
Strength
6UG/1ML
Approval Date
-
Active Ingredient
ZINC SULFATE HEPTAHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID
Application Number
219632
Product Number
6
Dosage Form
-
Strength
6UG/1ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ZINC SULFATE HEPTAHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID
Product Number
7
Dosage Form
-
Strength
3UG/1ML
Approval Date
-
Active Ingredient
ZINC SULFATE HEPTAHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID
Application Number
219632
Product Number
7
Dosage Form
-
Strength
3UG/1ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ZIPRASIDONE MESYLATE
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE/VIAL
Approval Date
2019-12-26
Active Ingredient
ZIPRASIDONE MESYLATE
Application Number
211908
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE/VIAL
Approval Date
2019-12-26
Regulatory Status
RX
Drug Name
ZOLEDRONIC
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE/100ML
Approval Date
2018-06-29
Active Ingredient
ZOLEDRONIC ACID
Application Number
205749
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE/100ML
Approval Date
2018-06-29
Regulatory Status
RX
Drug Name
ZOLEDRONIC ACID
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE/5ML
Approval Date
2013-08-05
Active Ingredient
ZOLEDRONIC ACID
Application Number
202930
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE/5ML
Approval Date
2013-08-05
Regulatory Status
RX
Drug Name
ZOLEDRONIC ACID
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/100ML
Approval Date
2016-08-18
Active Ingredient
ZOLEDRONIC ACID
Application Number
204217
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/100ML
Approval Date
2016-08-18
Regulatory Status
RX
Drug Name
ZOLEDRONIC ACID
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/100ML
Approval Date
2019-08-08
Active Ingredient
ZOLEDRONIC ACID
Application Number
209578
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/100ML
Approval Date
2019-08-08
Regulatory Status
RX
Drug Name
ZOLEDRONIC ACID
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE/100ML
Approval Date
2026-02-05
Active Ingredient
ZOLEDRONIC ACID
Application Number
219984
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE/100ML
Approval Date
2026-02-05
Regulatory Status
RX
Drug Status Breakdown
240 total- RX
- OTC
- Unclassified
- Discontinued
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
ACETAMINOPHEN
Application Number
219215
Product Number
1
Active Ingredient
ACETAMINOPHEN
Dosage Form
-
Strength
500MG/50ML (10MG/ML)
FDA Approved Drug Data
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