Eugia Pharma RX
FDA Approved Drugs
Eugia Pharma 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 171
- Latest Approval Date Feb 25, 2026
- Data Source FDA
- First Approval Date Dec 28, 2001
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Eugia Pharma RX
Forming part of Sy No 83/1, Hyderabad Knowledge City TSIIC Raidurg, Panmaktha Plot, 1, Hitech City Rd, opp. IKEA Hyderabad, Telangana 500081
India
www.eugiapharma.com/ info@eugia.co.in View on MapFDA Approved Drug Records ( 171 records )
Drug Name
ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
1GM/100ML (10MG/ML)
Approval Date
2020-10-21
Active Ingredient
ACETAMINOPHEN
Application Number
210969
Product Number
1
Dosage Form
-
Strength
1GM/100ML (10MG/ML)
Approval Date
2020-10-21
Regulatory Status
RX
Drug Name
ACETYLCYSTEINE
Product Number
1
Dosage Form
-
Strength
6GM/30ML (200MG/ML)
Approval Date
2016-02-29
Active Ingredient
ACETYLCYSTEINE
Application Number
207358
Product Number
1
Dosage Form
-
Strength
6GM/30ML (200MG/ML)
Approval Date
2016-02-29
Regulatory Status
RX
Drug Name
ACYCLOVIR SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/ML
Approval Date
2013-10-11
Active Ingredient
ACYCLOVIR SODIUM
Application Number
203701
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/ML
Approval Date
2013-10-11
Regulatory Status
RX
Drug Name
ADENOSINE
Product Number
1
Dosage Form
-
Strength
60MG/20ML (3MG/ML)
Approval Date
2017-11-02
Active Ingredient
ADENOSINE
Application Number
205331
Product Number
1
Dosage Form
-
Strength
60MG/20ML (3MG/ML)
Approval Date
2017-11-02
Regulatory Status
RX
Drug Name
ADENOSINE
Product Number
2
Dosage Form
-
Strength
90MG/30ML (3MG/ML)
Approval Date
2017-11-02
Active Ingredient
ADENOSINE
Application Number
205331
Product Number
2
Dosage Form
-
Strength
90MG/30ML (3MG/ML)
Approval Date
2017-11-02
Regulatory Status
RX
Drug Name
AMPHOTERICIN B
Product Number
1
Dosage Form
-
Strength
50MG/VIAL
Approval Date
2022-11-17
Active Ingredient
AMPHOTERICIN B
Application Number
214010
Product Number
1
Dosage Form
-
Strength
50MG/VIAL
Approval Date
2022-11-17
Regulatory Status
RX
Drug Name
ANASTROZOLE
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2020-07-24
Active Ingredient
ANASTROZOLE
Application Number
212434
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2020-07-24
Regulatory Status
RX
Drug Name
AZACITIDINE
Product Number
1
Dosage Form
-
Strength
100MG/VIAL
Approval Date
2022-12-30
Active Ingredient
AZACITIDINE
Application Number
215066
Product Number
1
Dosage Form
-
Strength
100MG/VIAL
Approval Date
2022-12-30
Regulatory Status
RX
Drug Name
AZITHROMYCIN
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2015-06-19
Active Ingredient
AZITHROMYCIN
Application Number
203294
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2015-06-19
Regulatory Status
RX
Drug Name
BENDAMUSTINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
25MG/VIAL
Approval Date
2023-06-05
Active Ingredient
BENDAMUSTINE HYDROCHLORIDE
Application Number
214739
Product Number
1
Dosage Form
-
Strength
25MG/VIAL
Approval Date
2023-06-05
Regulatory Status
RX
Drug Name
BENDAMUSTINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
100MG/VIAL
Approval Date
2023-06-05
Active Ingredient
BENDAMUSTINE HYDROCHLORIDE
Application Number
214739
Product Number
2
Dosage Form
-
Strength
100MG/VIAL
Approval Date
2023-06-05
Regulatory Status
RX
Drug Name
BIMATOPROST
Product Number
1
Dosage Form
-
Strength
0.03%
Approval Date
2022-10-06
Active Ingredient
BIMATOPROST
Application Number
205537
Product Number
1
Dosage Form
-
Strength
0.03%
Approval Date
2022-10-06
Regulatory Status
RX
Drug Name
BORTEZOMIB
Product Number
1
Dosage Form
-
Strength
3.5MG/VIAL
Approval Date
2022-05-02
Active Ingredient
BORTEZOMIB
Application Number
212825
Product Number
1
Dosage Form
-
Strength
3.5MG/VIAL
Approval Date
2022-05-02
Regulatory Status
RX
Drug Name
BROMFENAC SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 0.09% ACID
Approval Date
2022-03-18
Active Ingredient
BROMFENAC SODIUM
Application Number
204813
Product Number
1
Dosage Form
-
Strength
EQ 0.09% ACID
Approval Date
2022-03-18
Regulatory Status
RX
Drug Name
BUDESONIDE
Product Number
1
Dosage Form
-
Strength
0.5MG/2ML
Approval Date
2023-11-29
Active Ingredient
BUDESONIDE
Application Number
216667
Product Number
1
Dosage Form
-
Strength
0.5MG/2ML
Approval Date
2023-11-29
Regulatory Status
RX
Drug Name
BUPIVACAINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
0.25%
Approval Date
2016-05-13
Active Ingredient
BUPIVACAINE HYDROCHLORIDE
Application Number
207183
Product Number
1
Dosage Form
-
Strength
0.25%
Approval Date
2016-05-13
Regulatory Status
RX
Drug Name
BUPIVACAINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
0.5%
Approval Date
2016-05-13
Active Ingredient
BUPIVACAINE HYDROCHLORIDE
Application Number
207183
Product Number
2
Dosage Form
-
Strength
0.5%
Approval Date
2016-05-13
Regulatory Status
RX
Drug Name
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
Product Number
1
Dosage Form
-
Strength
0.25%
Approval Date
2013-11-05
Active Ingredient
BUPIVACAINE HYDROCHLORIDE
Application Number
203895
Product Number
1
Dosage Form
-
Strength
0.25%
Approval Date
2013-11-05
Regulatory Status
RX
Drug Name
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
Product Number
2
Dosage Form
-
Strength
0.5%
Approval Date
2013-11-05
Active Ingredient
BUPIVACAINE HYDROCHLORIDE
Application Number
203895
Product Number
2
Dosage Form
-
Strength
0.5%
Approval Date
2013-11-05
Regulatory Status
RX
Drug Name
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
Product Number
3
Dosage Form
-
Strength
0.75%
Approval Date
2013-11-05
Active Ingredient
BUPIVACAINE HYDROCHLORIDE
Application Number
203895
Product Number
3
Dosage Form
-
Strength
0.75%
Approval Date
2013-11-05
Regulatory Status
RX
Drug Name
CAPECITABINE
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
2018-04-17
Active Ingredient
CAPECITABINE
Application Number
210604
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
2018-04-17
Regulatory Status
RX
Drug Name
CAPECITABINE
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2018-04-17
Active Ingredient
CAPECITABINE
Application Number
210604
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2018-04-17
Regulatory Status
RX
Drug Name
CARBOPLATIN
Product Number
1
Dosage Form
-
Strength
50MG/5ML (10MG/ML)
Approval Date
2016-03-28
Active Ingredient
CARBOPLATIN
Application Number
205487
Product Number
1
Dosage Form
-
Strength
50MG/5ML (10MG/ML)
Approval Date
2016-03-28
Regulatory Status
RX
Drug Name
CARBOPLATIN
Product Number
2
Dosage Form
-
Strength
150MG/15ML (10MG/ML)
Approval Date
2016-03-28
Active Ingredient
CARBOPLATIN
Application Number
205487
Product Number
2
Dosage Form
-
Strength
150MG/15ML (10MG/ML)
Approval Date
2016-03-28
Regulatory Status
RX
Drug Name
CARBOPLATIN
Product Number
3
Dosage Form
-
Strength
450MG/45ML (10MG/ML)
Approval Date
2016-03-28
Active Ingredient
CARBOPLATIN
Application Number
205487
Product Number
3
Dosage Form
-
Strength
450MG/45ML (10MG/ML)
Approval Date
2016-03-28
Regulatory Status
RX
Drug Name
CARBOPLATIN
Product Number
4
Dosage Form
-
Strength
600MG/60ML (10MG/ML)
Approval Date
2020-08-03
Active Ingredient
CARBOPLATIN
Application Number
205487
Product Number
4
Dosage Form
-
Strength
600MG/60ML (10MG/ML)
Approval Date
2020-08-03
Regulatory Status
RX
Drug Name
CARBOPROST TROMETHAMINE
Product Number
1
Dosage Form
-
Strength
EQ 0.25MG BASE/ML
Approval Date
2023-05-25
Active Ingredient
CARBOPROST TROMETHAMINE
Application Number
216939
Product Number
1
Dosage Form
-
Strength
EQ 0.25MG BASE/ML
Approval Date
2023-05-25
Regulatory Status
RX
Drug Name
CHLORPROMAZINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
25MG/ML
Approval Date
2020-07-07
Active Ingredient
CHLORPROMAZINE HYDROCHLORIDE
Application Number
211816
Product Number
1
Dosage Form
-
Strength
25MG/ML
Approval Date
2020-07-07
Regulatory Status
RX
Drug Name
CYANOCOBALAMIN
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2020-12-08
Active Ingredient
CYANOCOBALAMIN
Application Number
213874
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2020-12-08
Regulatory Status
RX
Drug Name
DACTINOMYCIN
Product Number
1
Dosage Form
-
Strength
0.5MG/VIAL
Approval Date
2017-11-09
Active Ingredient
DACTINOMYCIN
Application Number
203385
Product Number
1
Dosage Form
-
Strength
0.5MG/VIAL
Approval Date
2017-11-09
Regulatory Status
RX
Drug Name
DAPTOMYCIN
Product Number
1
Dosage Form
-
Strength
500MG/VIAL
Approval Date
2021-09-02
Active Ingredient
DAPTOMYCIN
Application Number
213171
Product Number
1
Dosage Form
-
Strength
500MG/VIAL
Approval Date
2021-09-02
Regulatory Status
RX
Drug Name
DASATINIB
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2025-04-22
Active Ingredient
DASATINIB
Application Number
216547
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2025-04-22
Regulatory Status
RX
Drug Name
DASATINIB
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2025-04-22
Active Ingredient
DASATINIB
Application Number
216547
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2025-04-22
Regulatory Status
RX
Drug Name
DASATINIB
Product Number
3
Dosage Form
-
Strength
70MG
Approval Date
2025-04-22
Active Ingredient
DASATINIB
Application Number
216547
Product Number
3
Dosage Form
-
Strength
70MG
Approval Date
2025-04-22
Regulatory Status
RX
Drug Name
DASATINIB
Product Number
4
Dosage Form
-
Strength
80MG
Approval Date
2025-04-22
Active Ingredient
DASATINIB
Application Number
216547
Product Number
4
Dosage Form
-
Strength
80MG
Approval Date
2025-04-22
Regulatory Status
RX
Drug Name
DASATINIB
Product Number
5
Dosage Form
-
Strength
100MG
Approval Date
2025-04-22
Active Ingredient
DASATINIB
Application Number
216547
Product Number
5
Dosage Form
-
Strength
100MG
Approval Date
2025-04-22
Regulatory Status
RX
Drug Name
DASATINIB
Product Number
6
Dosage Form
-
Strength
140MG
Approval Date
2025-04-22
Active Ingredient
DASATINIB
Application Number
216547
Product Number
6
Dosage Form
-
Strength
140MG
Approval Date
2025-04-22
Regulatory Status
RX
Drug Name
DEXAMETHASONE SODIUM PHOSPHATE
Product Number
1
Dosage Form
-
Strength
EQ 10MG PHOSPHATE/ML
Approval Date
2020-06-05
Active Ingredient
DEXAMETHASONE SODIUM PHOSPHATE
Application Number
210966
Product Number
1
Dosage Form
-
Strength
EQ 10MG PHOSPHATE/ML
Approval Date
2020-06-05
Regulatory Status
RX
Drug Name
DEXMEDETOMIDINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)
Approval Date
2016-03-17
Active Ingredient
DEXMEDETOMIDINE HYDROCHLORIDE
Application Number
205867
Product Number
1
Dosage Form
-
Strength
EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)
Approval Date
2016-03-17
Regulatory Status
RX
Drug Name
DEXMEDETOMIDINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)
Approval Date
2020-12-07
Active Ingredient
DEXMEDETOMIDINE HYDROCHLORIDE
Application Number
210321
Product Number
1
Dosage Form
-
Strength
EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)
Approval Date
2020-12-07
Regulatory Status
RX
Drug Name
DEXMEDETOMIDINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)
Approval Date
2020-12-07
Active Ingredient
DEXMEDETOMIDINE HYDROCHLORIDE
Application Number
210321
Product Number
2
Dosage Form
-
Strength
EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)
Approval Date
2020-12-07
Regulatory Status
RX
Drug Name
DEXRAZOXANE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE/VIAL
Approval Date
2011-10-19
Active Ingredient
DEXRAZOXANE HYDROCHLORIDE
Application Number
200752
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE/VIAL
Approval Date
2011-10-19
Regulatory Status
RX
Drug Name
DEXRAZOXANE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2011-10-19
Active Ingredient
DEXRAZOXANE HYDROCHLORIDE
Application Number
200752
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2011-10-19
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
2021-05-14
Active Ingredient
DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE
Application Number
207629
Product Number
1
Dosage Form
-
Strength
EQ 2% BASE;EQ 0.5% BASE
Approval Date
2021-05-14
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
2018-07-24
Active Ingredient
DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE
Application Number
207630
Product Number
1
Dosage Form
-
Strength
EQ 2% BASE;EQ 0.5% BASE
Approval Date
2018-07-24
Regulatory Status
RX
Drug Name
EPHEDRINE SULFATE
Product Number
1
Dosage Form
-
Strength
50MG/ML (50MG/ML)
Approval Date
2021-06-14
Active Ingredient
EPHEDRINE SULFATE
Application Number
214579
Product Number
1
Dosage Form
-
Strength
50MG/ML (50MG/ML)
Approval Date
2021-06-14
Regulatory Status
RX
Drug Name
EPTIFIBATIDE
Product Number
1
Dosage Form
-
Strength
2MG/ML
Approval Date
2015-12-08
Active Ingredient
EPTIFIBATIDE
Application Number
206127
Product Number
1
Dosage Form
-
Strength
2MG/ML
Approval Date
2015-12-08
Regulatory Status
RX
Drug Name
EPTIFIBATIDE
Product Number
2
Dosage Form
-
Strength
75MG/100ML
Approval Date
2015-12-08
Active Ingredient
EPTIFIBATIDE
Application Number
206127
Product Number
2
Dosage Form
-
Strength
75MG/100ML
Approval Date
2015-12-08
Regulatory Status
RX
Drug Name
ERTAPENEM SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
2018-06-25
Active Ingredient
ERTAPENEM SODIUM
Application Number
209133
Product Number
1
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
2018-06-25
Regulatory Status
RX
Drug Name
ESMOLOL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2015-07-23
Active Ingredient
ESMOLOL HYDROCHLORIDE
Application Number
205520
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2015-07-23
Regulatory Status
RX
Drug Name
ESMOLOL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
1GM/100ML
Approval Date
2022-03-21
Active Ingredient
ESMOLOL HYDROCHLORIDE
Application Number
216244
Product Number
1
Dosage Form
-
Strength
1GM/100ML
Approval Date
2022-03-21
Regulatory Status
RX
Drug Name
ESMOLOL HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
2GM/100ML
Approval Date
2022-03-21
Active Ingredient
ESMOLOL HYDROCHLORIDE
Application Number
216244
Product Number
2
Dosage Form
-
Strength
2GM/100ML
Approval Date
2022-03-21
Regulatory Status
RX
Drug Name
ETOMIDATE
Product Number
1
Dosage Form
-
Strength
2MG/ML
Approval Date
2017-02-24
Active Ingredient
ETOMIDATE
Application Number
206126
Product Number
1
Dosage Form
-
Strength
2MG/ML
Approval Date
2017-02-24
Regulatory Status
RX
Drug Name
EVEROLIMUS
Product Number
1
Dosage Form
-
Strength
0.25MG
Approval Date
2026-02-25
Active Ingredient
EVEROLIMUS
Application Number
219533
Product Number
1
Dosage Form
-
Strength
0.25MG
Approval Date
2026-02-25
Regulatory Status
RX
Drug Name
EVEROLIMUS
Product Number
2
Dosage Form
-
Strength
0.5MG
Approval Date
2026-02-25
Active Ingredient
EVEROLIMUS
Application Number
219533
Product Number
2
Dosage Form
-
Strength
0.5MG
Approval Date
2026-02-25
Regulatory Status
RX
Drug Name
EVEROLIMUS
Product Number
3
Dosage Form
-
Strength
0.75MG
Approval Date
2026-02-25
Active Ingredient
EVEROLIMUS
Application Number
219533
Product Number
3
Dosage Form
-
Strength
0.75MG
Approval Date
2026-02-25
Regulatory Status
RX
Drug Name
EVEROLIMUS
Product Number
4
Dosage Form
-
Strength
1MG
Approval Date
2026-02-25
Active Ingredient
EVEROLIMUS
Application Number
219533
Product Number
4
Dosage Form
-
Strength
1MG
Approval Date
2026-02-25
Regulatory Status
RX
Drug Name
EXEMESTANE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2022-05-20
Active Ingredient
EXEMESTANE
Application Number
216454
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2022-05-20
Regulatory Status
RX
Drug Name
FLUPHENAZINE DECANOATE
Product Number
1
Dosage Form
-
Strength
25MG/ML
Approval Date
2017-10-17
Active Ingredient
FLUPHENAZINE DECANOATE
Application Number
207739
Product Number
1
Dosage Form
-
Strength
25MG/ML
Approval Date
2017-10-17
Regulatory Status
RX
Drug Name
FONDAPARINUX SODIUM
Product Number
1
Dosage Form
-
Strength
2.5MG/0.5ML (2.5MG/0.5ML)
Approval Date
2017-12-26
Active Ingredient
FONDAPARINUX SODIUM
Application Number
206918
Product Number
1
Dosage Form
-
Strength
2.5MG/0.5ML (2.5MG/0.5ML)
Approval Date
2017-12-26
Regulatory Status
RX
Drug Name
FONDAPARINUX SODIUM
Product Number
2
Dosage Form
-
Strength
5MG/0.4ML (5MG/0.4ML)
Approval Date
2017-12-26
Active Ingredient
FONDAPARINUX SODIUM
Application Number
206918
Product Number
2
Dosage Form
-
Strength
5MG/0.4ML (5MG/0.4ML)
Approval Date
2017-12-26
Regulatory Status
RX
Drug Name
FONDAPARINUX SODIUM
Product Number
3
Dosage Form
-
Strength
7.5MG/0.6ML (7.5MG/0.6ML)
Approval Date
2017-12-26
Active Ingredient
FONDAPARINUX SODIUM
Application Number
206918
Product Number
3
Dosage Form
-
Strength
7.5MG/0.6ML (7.5MG/0.6ML)
Approval Date
2017-12-26
Regulatory Status
RX
Drug Name
FONDAPARINUX SODIUM
Product Number
4
Dosage Form
-
Strength
10MG/0.8ML (10MG/0.8ML)
Approval Date
2017-12-26
Active Ingredient
FONDAPARINUX SODIUM
Application Number
206918
Product Number
4
Dosage Form
-
Strength
10MG/0.8ML (10MG/0.8ML)
Approval Date
2017-12-26
Regulatory Status
RX
Drug Name
FOSAPREPITANT DIMEGLUMINE
Product Number
1
Dosage Form
-
Strength
EQ 150MG BASE/VIAL
Approval Date
2021-01-12
Active Ingredient
FOSAPREPITANT DIMEGLUMINE
Application Number
210625
Product Number
1
Dosage Form
-
Strength
EQ 150MG BASE/VIAL
Approval Date
2021-01-12
Regulatory Status
RX
Drug Name
FUROSEMIDE
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2019-05-03
Active Ingredient
FUROSEMIDE
Application Number
212174
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2019-05-03
Regulatory Status
RX
Drug Name
GENTAMICIN SULFATE
Product Number
1
Dosage Form
-
Strength
EQ 40MG BASE/ML
Approval Date
2024-01-08
Active Ingredient
GENTAMICIN SULFATE
Application Number
215237
Product Number
1
Dosage Form
-
Strength
EQ 40MG BASE/ML
Approval Date
2024-01-08
Regulatory Status
RX
Drug Name
HYDRALAZINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
20MG/ML
Approval Date
2023-02-13
Active Ingredient
HYDRALAZINE HYDROCHLORIDE
Application Number
215147
Product Number
1
Dosage Form
-
Strength
20MG/ML
Approval Date
2023-02-13
Regulatory Status
RX
Drug Name
IBANDRONATE SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 3MG BASE/3ML
Approval Date
2015-08-19
Active Ingredient
IBANDRONATE SODIUM
Application Number
205332
Product Number
1
Dosage Form
-
Strength
EQ 3MG BASE/3ML
Approval Date
2015-08-19
Regulatory Status
RX
Drug Name
ICATIBANT ACETATE
Product Number
1
Dosage Form
-
Strength
EQ 30MG BASE/3ML (EQ 10MG BASE/ML)
Approval Date
2023-08-14
Active Ingredient
ICATIBANT ACETATE
Application Number
213521
Product Number
1
Dosage Form
-
Strength
EQ 30MG BASE/3ML (EQ 10MG BASE/ML)
Approval Date
2023-08-14
Regulatory Status
RX
Drug Name
IMATINIB MESYLATE
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2020-07-23
Active Ingredient
IMATINIB MESYLATE
Application Number
212773
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2020-07-23
Regulatory Status
RX
Drug Name
IMATINIB MESYLATE
Product Number
2
Dosage Form
-
Strength
EQ 400MG BASE
Approval Date
2020-07-23
Active Ingredient
IMATINIB MESYLATE
Application Number
212773
Product Number
2
Dosage Form
-
Strength
EQ 400MG BASE
Approval Date
2020-07-23
Regulatory Status
RX
Drug Name
IRINOTECAN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
40MG/2ML (20MG/ML)
Approval Date
2020-11-02
Active Ingredient
IRINOTECAN HYDROCHLORIDE
Application Number
213278
Product Number
1
Dosage Form
-
Strength
40MG/2ML (20MG/ML)
Approval Date
2020-11-02
Regulatory Status
RX
Drug Name
IRINOTECAN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
100MG/5ML (20MG/ML)
Approval Date
2020-11-02
Active Ingredient
IRINOTECAN HYDROCHLORIDE
Application Number
213278
Product Number
2
Dosage Form
-
Strength
100MG/5ML (20MG/ML)
Approval Date
2020-11-02
Regulatory Status
RX
Drug Name
IRINOTECAN HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
300MG/15ML (20MG/ML)
Approval Date
2020-11-02
Active Ingredient
IRINOTECAN HYDROCHLORIDE
Application Number
213278
Product Number
3
Dosage Form
-
Strength
300MG/15ML (20MG/ML)
Approval Date
2020-11-02
Regulatory Status
RX
Drug Name
IRINOTECAN HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
500MG/25ML (20MG/ML)
Approval Date
2022-04-11
Active Ingredient
IRINOTECAN HYDROCHLORIDE
Application Number
213278
Product Number
4
Dosage Form
-
Strength
500MG/25ML (20MG/ML)
Approval Date
2022-04-11
Regulatory Status
RX
Drug Name
ISOSULFAN BLUE
Product Number
1
Dosage Form
-
Strength
50MG/5ML (10MG/ML)
Approval Date
2016-02-02
Active Ingredient
ISOSULFAN BLUE
Application Number
206831
Product Number
1
Dosage Form
-
Strength
50MG/5ML (10MG/ML)
Approval Date
2016-02-02
Regulatory Status
RX
Drug Name
KETAMINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/ML
Approval Date
2008-09-30
Active Ingredient
KETAMINE HYDROCHLORIDE
Application Number
76092
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/ML
Approval Date
2008-09-30
Regulatory Status
RX
Drug Name
KETAMINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE/ML
Approval Date
2001-12-28
Active Ingredient
KETAMINE HYDROCHLORIDE
Application Number
76092
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE/ML
Approval Date
2001-12-28
Regulatory Status
RX
Drug Name
KETAMINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE/ML
Approval Date
2002-10-25
Active Ingredient
KETAMINE HYDROCHLORIDE
Application Number
76092
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE/ML
Approval Date
2002-10-25
Regulatory Status
RX
Drug Name
LENALIDOMIDE
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2023-03-06
Active Ingredient
LENALIDOMIDE
Application Number
213885
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2023-03-06
Regulatory Status
RX
Drug Name
LENALIDOMIDE
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2023-03-06
Active Ingredient
LENALIDOMIDE
Application Number
213885
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2023-03-06
Regulatory Status
RX
Drug Name
LENALIDOMIDE
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2023-03-06
Active Ingredient
LENALIDOMIDE
Application Number
213885
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2023-03-06
Regulatory Status
RX
Drug Name
LENALIDOMIDE
Product Number
4
Dosage Form
-
Strength
15MG
Approval Date
2023-03-06
Active Ingredient
LENALIDOMIDE
Application Number
213885
Product Number
4
Dosage Form
-
Strength
15MG
Approval Date
2023-03-06
Regulatory Status
RX
Drug Name
LENALIDOMIDE
Product Number
5
Dosage Form
-
Strength
20MG
Approval Date
2023-03-06
Active Ingredient
LENALIDOMIDE
Application Number
213885
Product Number
5
Dosage Form
-
Strength
20MG
Approval Date
2023-03-06
Regulatory Status
RX
Drug Name
LENALIDOMIDE
Product Number
6
Dosage Form
-
Strength
25MG
Approval Date
2023-03-06
Active Ingredient
LENALIDOMIDE
Application Number
213885
Product Number
6
Dosage Form
-
Strength
25MG
Approval Date
2023-03-06
Regulatory Status
RX
Drug Name
LETROZOLE
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2019-01-11
Active Ingredient
LETROZOLE
Application Number
211717
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2019-01-11
Regulatory Status
RX
Drug Name
LEUPROLIDE ACETATE
Product Number
1
Dosage Form
-
Strength
14MG/2.8ML (1MG/0.2ML)
Approval Date
2022-06-06
Active Ingredient
LEUPROLIDE ACETATE
Application Number
212963
Product Number
1
Dosage Form
-
Strength
14MG/2.8ML (1MG/0.2ML)
Approval Date
2022-06-06
Regulatory Status
RX
Drug Name
LEVETIRACETAM
Product Number
1
Dosage Form
-
Strength
500MG/5ML (100MG/ML)
Approval Date
2016-02-01
Active Ingredient
LEVETIRACETAM
Application Number
204312
Product Number
1
Dosage Form
-
Strength
500MG/5ML (100MG/ML)
Approval Date
2016-02-01
Regulatory Status
RX
Drug Name
LEVETIRACETAM IN SODIUM CHLORIDE
Product Number
1
Dosage Form
-
Strength
500MG/100ML (5MG/ML)
Approval Date
2017-01-04
Active Ingredient
LEVETIRACETAM
Application Number
207160
Product Number
1
Dosage Form
-
Strength
500MG/100ML (5MG/ML)
Approval Date
2017-01-04
Regulatory Status
RX
Drug Name
LEVETIRACETAM IN SODIUM CHLORIDE
Product Number
2
Dosage Form
-
Strength
1GM/100ML (10MG/ML)
Approval Date
2017-01-04
Active Ingredient
LEVETIRACETAM
Application Number
207160
Product Number
2
Dosage Form
-
Strength
1GM/100ML (10MG/ML)
Approval Date
2017-01-04
Regulatory Status
RX
Drug Name
LEVETIRACETAM IN SODIUM CHLORIDE
Product Number
3
Dosage Form
-
Strength
1.5GM/100ML (15MG/ML)
Approval Date
2017-01-04
Active Ingredient
LEVETIRACETAM
Application Number
207160
Product Number
3
Dosage Form
-
Strength
1.5GM/100ML (15MG/ML)
Approval Date
2017-01-04
Regulatory Status
RX
Drug Name
LIDOCAINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
2017-10-30
Active Ingredient
LIDOCAINE HYDROCHLORIDE
Application Number
207182
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
2017-10-30
Regulatory Status
RX
Drug Name
LIDOCAINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
2%
Approval Date
2017-10-30
Active Ingredient
LIDOCAINE HYDROCHLORIDE
Application Number
207182
Product Number
2
Dosage Form
-
Strength
2%
Approval Date
2017-10-30
Regulatory Status
RX
Drug Name
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
2013-03-14
Active Ingredient
LIDOCAINE HYDROCHLORIDE
Application Number
203082
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
2013-03-14
Regulatory Status
RX
Drug Name
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
Product Number
2
Dosage Form
-
Strength
2%
Approval Date
2013-03-14
Active Ingredient
LIDOCAINE HYDROCHLORIDE
Application Number
203082
Product Number
2
Dosage Form
-
Strength
2%
Approval Date
2013-03-14
Regulatory Status
RX
Drug Name
LINEZOLID
Product Number
1
Dosage Form
-
Strength
600MG/300ML (2MG/ML)
Approval Date
2016-08-04
Active Ingredient
LINEZOLID
Application Number
206917
Product Number
1
Dosage Form
-
Strength
600MG/300ML (2MG/ML)
Approval Date
2016-08-04
Regulatory Status
RX
Drug Name
MEDROXYPROGESTERONE ACETATE
Product Number
1
Dosage Form
-
Strength
150MG/ML
Approval Date
2022-08-22
Active Ingredient
MEDROXYPROGESTERONE ACETATE
Application Number
212824
Product Number
1
Dosage Form
-
Strength
150MG/ML
Approval Date
2022-08-22
Regulatory Status
RX
Drug Name
MEDROXYPROGESTERONE ACETATE
Product Number
1
Dosage Form
-
Strength
150MG/ML
Approval Date
2022-08-31
Active Ingredient
MEDROXYPROGESTERONE ACETATE
Application Number
212844
Product Number
1
Dosage Form
-
Strength
150MG/ML
Approval Date
2022-08-31
Regulatory Status
RX
Drug Name
MEROPENEM
Product Number
1
Dosage Form
-
Strength
500MG/VIAL
Approval Date
2017-03-27
Active Ingredient
MEROPENEM
Application Number
205835
Product Number
1
Dosage Form
-
Strength
500MG/VIAL
Approval Date
2017-03-27
Regulatory Status
RX
Drug Name
MEROPENEM
Product Number
2
Dosage Form
-
Strength
1GM/VIAL
Approval Date
2017-03-27
Active Ingredient
MEROPENEM
Application Number
205835
Product Number
2
Dosage Form
-
Strength
1GM/VIAL
Approval Date
2017-03-27
Regulatory Status
RX
Drug Name
MESNA
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2026-01-27
Active Ingredient
MESNA
Application Number
220518
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2026-01-27
Regulatory Status
RX
Drug Name
METHOCARBAMOL
Product Number
1
Dosage Form
-
Strength
1GM/10ML (100MG/ML)
Approval Date
2016-05-27
Active Ingredient
METHOCARBAMOL
Application Number
206128
Product Number
1
Dosage Form
-
Strength
1GM/10ML (100MG/ML)
Approval Date
2016-05-27
Regulatory Status
RX
Drug Name
METHOTREXATE SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE
Approval Date
2020-01-30
Active Ingredient
METHOTREXATE SODIUM
Application Number
210454
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE
Approval Date
2020-01-30
Regulatory Status
RX
Drug Name
METHYLPREDNISOLONE ACETATE
Product Number
1
Dosage Form
-
Strength
40MG/ML
Approval Date
2023-04-13
Active Ingredient
METHYLPREDNISOLONE ACETATE
Application Number
211930
Product Number
1
Dosage Form
-
Strength
40MG/ML
Approval Date
2023-04-13
Regulatory Status
RX
Drug Name
METHYLPREDNISOLONE ACETATE
Product Number
2
Dosage Form
-
Strength
80MG/ML
Approval Date
2023-04-13
Active Ingredient
METHYLPREDNISOLONE ACETATE
Application Number
211930
Product Number
2
Dosage Form
-
Strength
80MG/ML
Approval Date
2023-04-13
Regulatory Status
RX
Drug Name
MILRINONE LACTATE IN DEXTROSE 5%
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)
Approval Date
2020-09-03
Active Ingredient
MILRINONE LACTATE
Application Number
209666
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)
Approval Date
2020-09-03
Regulatory Status
RX
Drug Name
MILRINONE LACTATE IN DEXTROSE 5%
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)
Approval Date
2020-09-03
Active Ingredient
MILRINONE LACTATE
Application Number
209666
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)
Approval Date
2020-09-03
Regulatory Status
RX
Drug Name
MOXIFLOXACIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 0.5% BASE
Approval Date
2017-10-04
Active Ingredient
MOXIFLOXACIN HYDROCHLORIDE
Application Number
206242
Product Number
1
Dosage Form
-
Strength
EQ 0.5% BASE
Approval Date
2017-10-04
Regulatory Status
RX
Drug Name
NALOXONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
0.4MG/ML
Approval Date
2019-11-04
Active Ingredient
NALOXONE HYDROCHLORIDE
Application Number
212456
Product Number
1
Dosage Form
-
Strength
0.4MG/ML
Approval Date
2019-11-04
Regulatory Status
RX
Drug Name
NALOXONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2021-01-14
Active Ingredient
NALOXONE HYDROCHLORIDE
Application Number
213279
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2021-01-14
Regulatory Status
RX
Drug Name
NICARDIPINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
25MG/10ML (2.5MG/ML)
Approval Date
2021-04-08
Active Ingredient
NICARDIPINE HYDROCHLORIDE
Application Number
211121
Product Number
1
Dosage Form
-
Strength
25MG/10ML (2.5MG/ML)
Approval Date
2021-04-08
Regulatory Status
RX
Drug Name
OLANZAPINE
Product Number
1
Dosage Form
-
Strength
10MG/VIAL
Approval Date
2020-10-22
Active Ingredient
OLANZAPINE
Application Number
210968
Product Number
1
Dosage Form
-
Strength
10MG/VIAL
Approval Date
2020-10-22
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
2018-11-06
Active Ingredient
PALONOSETRON HYDROCHLORIDE
Application Number
204702
Product Number
1
Dosage Form
-
Strength
EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)
Approval Date
2018-11-06
Regulatory Status
RX
Drug Name
PANTOPRAZOLE SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 40MG BASE/VIAL
Approval Date
2016-03-30
Active Ingredient
PANTOPRAZOLE SODIUM
Application Number
205675
Product Number
1
Dosage Form
-
Strength
EQ 40MG BASE/VIAL
Approval Date
2016-03-30
Regulatory Status
RX
Drug Name
PAZOPANIB HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
2024-12-04
Active Ingredient
PAZOPANIB HYDROCHLORIDE
Application Number
219034
Product Number
1
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
2024-12-04
Regulatory Status
RX
Drug Name
PEMETREXED DISODIUM
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE/VIAL
Approval Date
2022-05-25
Active Ingredient
PEMETREXED DISODIUM
Application Number
214632
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE/VIAL
Approval Date
2022-05-25
Regulatory Status
RX
Drug Name
PEMETREXED DISODIUM
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2022-05-25
Active Ingredient
PEMETREXED DISODIUM
Application Number
214632
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2022-05-25
Regulatory Status
RX
Drug Name
PEMETREXED DISODIUM
Product Number
3
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
2022-05-25
Active Ingredient
PEMETREXED DISODIUM
Application Number
214632
Product Number
3
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
2022-05-25
Regulatory Status
RX
Drug Name
PHENYLEPHRINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG/ML (10MG/ML)
Approval Date
2021-01-07
Active Ingredient
PHENYLEPHRINE HYDROCHLORIDE
Application Number
210696
Product Number
1
Dosage Form
-
Strength
10MG/ML (10MG/ML)
Approval Date
2021-01-07
Regulatory Status
RX
Drug Name
PHENYLEPHRINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
50MG/5ML (10MG/ML)
Approval Date
2020-11-13
Active Ingredient
PHENYLEPHRINE HYDROCHLORIDE
Application Number
210697
Product Number
1
Dosage Form
-
Strength
50MG/5ML (10MG/ML)
Approval Date
2020-11-13
Regulatory Status
RX
Drug Name
PHENYLEPHRINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
100MG/10ML (10MG/ML)
Approval Date
2020-11-13
Active Ingredient
PHENYLEPHRINE HYDROCHLORIDE
Application Number
210697
Product Number
2
Dosage Form
-
Strength
100MG/10ML (10MG/ML)
Approval Date
2020-11-13
Regulatory Status
RX
Drug Name
PLERIXAFOR
Product Number
1
Dosage Form
-
Strength
24MG/1.2ML (20MG/ML)
Approval Date
2023-07-24
Active Ingredient
PLERIXAFOR
Application Number
213672
Product Number
1
Dosage Form
-
Strength
24MG/1.2ML (20MG/ML)
Approval Date
2023-07-24
Regulatory Status
RX
Drug Name
POLYMYXIN B SULFATE
Product Number
1
Dosage Form
-
Strength
EQ 500,000 UNITS BASE/VIAL
Approval Date
2016-04-04
Active Ingredient
POLYMYXIN B SULFATE
Application Number
206589
Product Number
1
Dosage Form
-
Strength
EQ 500,000 UNITS BASE/VIAL
Approval Date
2016-04-04
Regulatory Status
RX
Drug Name
POMALIDOMIDE
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2020-10-30
Active Ingredient
POMALIDOMIDE
Application Number
210249
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2020-10-30
Regulatory Status
RX
Drug Name
POMALIDOMIDE
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
2020-10-30
Active Ingredient
POMALIDOMIDE
Application Number
210249
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
2020-10-30
Regulatory Status
RX
Drug Name
POMALIDOMIDE
Product Number
3
Dosage Form
-
Strength
3MG
Approval Date
2020-10-30
Active Ingredient
POMALIDOMIDE
Application Number
210249
Product Number
3
Dosage Form
-
Strength
3MG
Approval Date
2020-10-30
Regulatory Status
RX
Drug Name
POMALIDOMIDE
Product Number
4
Dosage Form
-
Strength
4MG
Approval Date
2020-10-30
Active Ingredient
POMALIDOMIDE
Application Number
210249
Product Number
4
Dosage Form
-
Strength
4MG
Approval Date
2020-10-30
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
214842
Product Number
1
Dosage Form
-
Strength
300MG/16.7ML (18MG/ML)
Approval Date
2023-12-26
Regulatory Status
RX
Drug Name
PROCHLORPERAZINE EDISYLATE
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/ML
Approval Date
2022-07-14
Active Ingredient
PROCHLORPERAZINE EDISYLATE
Application Number
213873
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/ML
Approval Date
2022-07-14
Regulatory Status
RX
Drug Name
PROGESTERONE
Product Number
1
Dosage Form
-
Strength
50MG/ML
Approval Date
2018-12-06
Active Ingredient
PROGESTERONE
Application Number
210965
Product Number
1
Dosage Form
-
Strength
50MG/ML
Approval Date
2018-12-06
Regulatory Status
RX
Drug Name
PROGESTERONE
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2018-10-26
Active Ingredient
PROGESTERONE
Application Number
211285
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2018-10-26
Regulatory Status
RX
Drug Name
PROGESTERONE
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
2018-10-26
Active Ingredient
PROGESTERONE
Application Number
211285
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
2018-10-26
Regulatory Status
RX
Drug Name
REGADENOSON
Product Number
1
Dosage Form
-
Strength
0.4MG/5ML (0.08MG/ML)
Approval Date
2022-10-26
Active Ingredient
REGADENOSON
Application Number
216437
Product Number
1
Dosage Form
-
Strength
0.4MG/5ML (0.08MG/ML)
Approval Date
2022-10-26
Regulatory Status
RX
Drug Name
ROCURONIUM BROMIDE
Product Number
1
Dosage Form
-
Strength
50MG/5ML (10MG/ML)
Approval Date
2017-04-12
Active Ingredient
ROCURONIUM BROMIDE
Application Number
206206
Product Number
1
Dosage Form
-
Strength
50MG/5ML (10MG/ML)
Approval Date
2017-04-12
Regulatory Status
RX
Drug Name
ROCURONIUM BROMIDE
Product Number
2
Dosage Form
-
Strength
100MG/10ML (10MG/ML)
Approval Date
2017-04-12
Active Ingredient
ROCURONIUM BROMIDE
Application Number
206206
Product Number
2
Dosage Form
-
Strength
100MG/10ML (10MG/ML)
Approval Date
2017-04-12
Regulatory Status
RX
Drug Name
ROPIVACAINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
40MG/20ML (2MG/ML)
Approval Date
2016-07-13
Active Ingredient
ROPIVACAINE HYDROCHLORIDE
Application Number
205612
Product Number
1
Dosage Form
-
Strength
40MG/20ML (2MG/ML)
Approval Date
2016-07-13
Regulatory Status
RX
Drug Name
ROPIVACAINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
200MG/100ML (2MG/ML)
Approval Date
2016-07-13
Active Ingredient
ROPIVACAINE HYDROCHLORIDE
Application Number
205612
Product Number
2
Dosage Form
-
Strength
200MG/100ML (2MG/ML)
Approval Date
2016-07-13
Regulatory Status
RX
Drug Name
ROPIVACAINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
100MG/20ML (5MG/ML)
Approval Date
2016-07-13
Active Ingredient
ROPIVACAINE HYDROCHLORIDE
Application Number
205612
Product Number
3
Dosage Form
-
Strength
100MG/20ML (5MG/ML)
Approval Date
2016-07-13
Regulatory Status
RX
Drug Name
ROPIVACAINE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
150MG/30ML (5MG/ML)
Approval Date
2016-07-13
Active Ingredient
ROPIVACAINE HYDROCHLORIDE
Application Number
205612
Product Number
4
Dosage Form
-
Strength
150MG/30ML (5MG/ML)
Approval Date
2016-07-13
Regulatory Status
RX
Drug Name
ROPIVACAINE HYDROCHLORIDE
Product Number
5
Dosage Form
-
Strength
150MG/20ML (7.5MG/ML)
Approval Date
2016-07-13
Active Ingredient
ROPIVACAINE HYDROCHLORIDE
Application Number
205612
Product Number
5
Dosage Form
-
Strength
150MG/20ML (7.5MG/ML)
Approval Date
2016-07-13
Regulatory Status
RX
Drug Name
ROPIVACAINE HYDROCHLORIDE
Product Number
6
Dosage Form
-
Strength
100MG/10ML (10MG/ML)
Approval Date
2016-07-13
Active Ingredient
ROPIVACAINE HYDROCHLORIDE
Application Number
205612
Product Number
6
Dosage Form
-
Strength
100MG/10ML (10MG/ML)
Approval Date
2016-07-13
Regulatory Status
RX
Drug Name
ROPIVACAINE HYDROCHLORIDE
Product Number
7
Dosage Form
-
Strength
200MG/20ML (10MG/ML)
Approval Date
2016-07-13
Active Ingredient
ROPIVACAINE HYDROCHLORIDE
Application Number
205612
Product Number
7
Dosage Form
-
Strength
200MG/20ML (10MG/ML)
Approval Date
2016-07-13
Regulatory Status
RX
Drug Name
SILDENAFIL CITRATE
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)
Approval Date
2015-04-01
Active Ingredient
SILDENAFIL CITRATE
Application Number
203988
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)
Approval Date
2015-04-01
Regulatory Status
RX
Drug Name
SUMATRIPTAN SUCCINATE
Product Number
1
Dosage Form
-
Strength
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
Approval Date
2013-04-23
Active Ingredient
SUMATRIPTAN SUCCINATE
Application Number
202758
Product Number
1
Dosage Form
-
Strength
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
Approval Date
2013-04-23
Regulatory Status
RX
Drug Name
SUNITINIB MALATE
Product Number
1
Dosage Form
-
Strength
EQ 12.5MG BASE
Approval Date
2024-03-14
Active Ingredient
SUNITINIB MALATE
Application Number
218615
Product Number
1
Dosage Form
-
Strength
EQ 12.5MG BASE
Approval Date
2024-03-14
Regulatory Status
RX
Drug Name
SUNITINIB MALATE
Product Number
2
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2024-03-14
Active Ingredient
SUNITINIB MALATE
Application Number
218615
Product Number
2
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2024-03-14
Regulatory Status
RX
Drug Name
SUNITINIB MALATE
Product Number
3
Dosage Form
-
Strength
EQ 37.5MG BASE
Approval Date
2024-03-14
Active Ingredient
SUNITINIB MALATE
Application Number
218615
Product Number
3
Dosage Form
-
Strength
EQ 37.5MG BASE
Approval Date
2024-03-14
Regulatory Status
RX
Drug Name
SUNITINIB MALATE
Product Number
4
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2024-03-14
Active Ingredient
SUNITINIB MALATE
Application Number
218615
Product Number
4
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2024-03-14
Regulatory Status
RX
Drug Name
TAMOXIFEN CITRATE
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2020-08-14
Active Ingredient
TAMOXIFEN CITRATE
Application Number
213358
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2020-08-14
Regulatory Status
RX
Drug Name
TAMOXIFEN CITRATE
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2020-08-14
Active Ingredient
TAMOXIFEN CITRATE
Application Number
213358
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2020-08-14
Regulatory Status
RX
Drug Name
TESTOSTERONE CYPIONATE
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2023-10-20
Active Ingredient
TESTOSTERONE CYPIONATE
Application Number
211817
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2023-10-20
Regulatory Status
RX
Drug Name
TESTOSTERONE CYPIONATE
Product Number
2
Dosage Form
-
Strength
200MG/ML
Approval Date
2023-10-20
Active Ingredient
TESTOSTERONE CYPIONATE
Application Number
211817
Product Number
2
Dosage Form
-
Strength
200MG/ML
Approval Date
2023-10-20
Regulatory Status
RX
Drug Name
TESTOSTERONE ENANTHATE
Product Number
1
Dosage Form
-
Strength
200MG/ML
Approval Date
2024-02-28
Active Ingredient
TESTOSTERONE ENANTHATE
Application Number
212659
Product Number
1
Dosage Form
-
Strength
200MG/ML
Approval Date
2024-02-28
Regulatory Status
RX
Drug Name
THIAMINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2022-04-20
Active Ingredient
THIAMINE HYDROCHLORIDE
Application Number
208703
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2022-04-20
Regulatory Status
RX
Drug Name
TIGECYCLINE
Product Number
1
Dosage Form
-
Strength
50MG/VIAL
Approval Date
2019-06-11
Active Ingredient
TIGECYCLINE
Application Number
206335
Product Number
1
Dosage Form
-
Strength
50MG/VIAL
Approval Date
2019-06-11
Regulatory Status
RX
Drug Name
TIMOLOL MALEATE
Product Number
1
Dosage Form
-
Strength
EQ 0.5% BASE
Approval Date
2023-03-23
Active Ingredient
TIMOLOL MALEATE
Application Number
213540
Product Number
1
Dosage Form
-
Strength
EQ 0.5% BASE
Approval Date
2023-03-23
Regulatory Status
RX
Drug Name
TIROFIBAN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)
Approval Date
2023-05-01
Active Ingredient
TIROFIBAN HYDROCHLORIDE
Application Number
216379
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)
Approval Date
2023-05-01
Regulatory Status
RX
Drug Name
TIROFIBAN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)
Approval Date
2023-05-01
Active Ingredient
TIROFIBAN HYDROCHLORIDE
Application Number
216379
Product Number
2
Dosage Form
-
Strength
EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)
Approval Date
2023-05-01
Regulatory Status
RX
Drug Name
TOBRAMYCIN SULFATE
Product Number
1
Dosage Form
-
Strength
EQ 1.2GM BASE/VIAL
Approval Date
2023-06-21
Active Ingredient
TOBRAMYCIN SULFATE
Application Number
217519
Product Number
1
Dosage Form
-
Strength
EQ 1.2GM BASE/VIAL
Approval Date
2023-06-21
Regulatory Status
RX
Drug Name
TRANEXAMIC ACID
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2016-01-14
Active Ingredient
TRANEXAMIC ACID
Application Number
205035
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2016-01-14
Regulatory Status
RX
Drug Name
TRIAMCINOLONE ACETONIDE
Product Number
1
Dosage Form
-
Strength
40MG/ML
Approval Date
2022-07-05
Active Ingredient
TRIAMCINOLONE ACETONIDE
Application Number
212400
Product Number
1
Dosage Form
-
Strength
40MG/ML
Approval Date
2022-07-05
Regulatory Status
RX
Drug Name
VANCOMYCIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 5GM BASE/VIAL
Approval Date
2016-03-29
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
205779
Product Number
1
Dosage Form
-
Strength
EQ 5GM BASE/VIAL
Approval Date
2016-03-29
Regulatory Status
RX
Drug Name
VANCOMYCIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 10GM BASE/VIAL
Approval Date
2016-03-29
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
205779
Product Number
2
Dosage Form
-
Strength
EQ 10GM BASE/VIAL
Approval Date
2016-03-29
Regulatory Status
RX
Drug Name
VANCOMYCIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2016-03-31
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
205780
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2016-03-31
Regulatory Status
RX
Drug Name
VANCOMYCIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
2016-03-31
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
205780
Product Number
2
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
2016-03-31
Regulatory Status
RX
Drug Name
VANCOMYCIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 1.25GM BASE/VIAL
Approval Date
2023-08-04
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
217401
Product Number
1
Dosage Form
-
Strength
EQ 1.25GM BASE/VIAL
Approval Date
2023-08-04
Regulatory Status
RX
Drug Name
VANCOMYCIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 1.5GM BASE/VIAL
Approval Date
2023-08-04
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
217401
Product Number
2
Dosage Form
-
Strength
EQ 1.5GM BASE/VIAL
Approval Date
2023-08-04
Regulatory Status
RX
Drug Name
VASOPRESSIN
Product Number
1
Dosage Form
-
Strength
20UNITS/ML (20UNITS/ML)
Approval Date
2022-08-15
Active Ingredient
VASOPRESSIN
Application Number
214314
Product Number
1
Dosage Form
-
Strength
20UNITS/ML (20UNITS/ML)
Approval Date
2022-08-15
Regulatory Status
RX
Drug Name
VECURONIUM BROMIDE
Product Number
1
Dosage Form
-
Strength
10MG/VIAL
Approval Date
2018-12-20
Active Ingredient
VECURONIUM BROMIDE
Application Number
206670
Product Number
1
Dosage Form
-
Strength
10MG/VIAL
Approval Date
2018-12-20
Regulatory Status
RX
Drug Name
VECURONIUM BROMIDE
Product Number
2
Dosage Form
-
Strength
20MG/VIAL
Approval Date
2018-12-20
Active Ingredient
VECURONIUM BROMIDE
Application Number
206670
Product Number
2
Dosage Form
-
Strength
20MG/VIAL
Approval Date
2018-12-20
Regulatory Status
RX
Drug Name
VERAPAMIL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
2.5MG/ML
Approval Date
2020-07-06
Active Ingredient
VERAPAMIL HYDROCHLORIDE
Application Number
212965
Product Number
1
Dosage Form
-
Strength
2.5MG/ML
Approval Date
2020-07-06
Regulatory Status
RX
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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
210969
Product Number
1
Active Ingredient
ACETAMINOPHEN
Dosage Form
-
Strength
1GM/100ML (10MG/ML)
FDA Approved Drug Data
Approved drug product information
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