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Approved Drug Products of Bionpharma listed in the FDA Orange Book. Original Data : FDA Website

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01 ACETAMINOPHEN; IBUPROFEN (1)

02 AMANTADINE HYDROCHLORIDE (1)

03 AMPHETAMINE SULFATE (2)

04 APIXABAN (2)

05 ATOVAQUONE (1)

06 AZELASTINE HYDROCHLORIDE (1)

07 AZITHROMYCIN (3)

08 BENZONATATE (2)

09 BEXAROTENE (1)

10 BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE (1)

11 CALCITRIOL (2)

12 CARBAMAZEPINE (1)

13 CETIRIZINE HYDROCHLORIDE (5)

14 CEVIMELINE HYDROCHLORIDE (1)

15 CLOBAZAM (3)

16 COLESEVELAM HYDROCHLORIDE (1)

17 DEFERASIROX (3)

18 DEXAMETHASONE (3)

19 DEXMETHYLPHENIDATE HYDROCHLORIDE (2)

20 DICLOFENAC POTASSIUM (1)

21 DICYCLOMINE HYDROCHLORIDE (1)

22 DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN (1)

23 DOFETILIDE (3)

24 DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE (1)

25 DROXIDOPA (3)

26 DUTASTERIDE (1)

27 ENALAPRIL MALEATE (1)

28 ERGOCALCIFEROL (1)

29 ETHOSUXIMIDE (1)

30 FINGOLIMOD HYDROCHLORIDE (1)

31 FLUVOXAMINE MALEATE (5)

32 GRANISETRON HYDROCHLORIDE (3)

33 IBUPROFEN (2)

34 KETOROLAC TROMETHAMINE (1)

35 LEVETIRACETAM (1)

36 LIDOCAINE HYDROCHLORIDE (1)

37 LOPERAMIDE HYDROCHLORIDE (3)

38 LOPERAMIDE HYDROCHLORIDE; SIMETHICONE (1)

39 LORATADINE (1)

40 MEGESTROL ACETATE (1)

41 METHIMAZOLE (2)

42 METHYLPHENIDATE HYDROCHLORIDE (3)

43 NAPROXEN SODIUM (1)

44 NICARDIPINE HYDROCHLORIDE (2)

45 NIMODIPINE (1)

46 OMEGA-3-ACID ETHYL ESTERS (1)

47 OXCARBAZEPINE (1)

48 OXYBUTYNIN CHLORIDE (3)

49 PARICALCITOL (3)

50 POTASSIUM CITRATE (2)

51 PROCHLORPERAZINE MALEATE (2)

52 PROGESTERONE (2)

53 RUFINAMIDE (1)

54 SEVELAMER CARBONATE (1)

55 TERAZOSIN HYDROCHLORIDE (4)

56 TETRABENAZINE (2)

57 THEOPHYLLINE (2)

58 VALPROIC ACID (4)

59 ZONISAMIDE (3)

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01 CAPSULE, DELAYED RELEASE;ORAL (3)

02 CAPSULE, EXTENDED RELEASE;ORAL (2)

03 CAPSULE;ORAL (47)

04 FOR SUSPENSION;ORAL (1)

05 INJECTABLE;INJECTION (3)

06 JELLY;TOPICAL (1)

07 SOLUTION;ORAL (3)

08 SPRAY, METERED;NASAL (1)

09 SUSPENSION;ORAL (5)

10 SYRUP;ORAL (1)

11 TABLET, DELAYED RELEASE;ORAL (1)

12 TABLET, EXTENDED RELEASE;ORAL (7)

13 TABLET, FOR SUSPENSION;ORAL (3)

14 TABLET;ORAL (32)

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01 0.125MG (1)

02 0.137MG/SPRAY (1)

03 0.25MCG (1)

04 0.25MG (1)

05 0.5MCG (1)

06 0.5MG (2)

07 100MG (7)

08 100MG/ML (1)

09 10MEQ (1)

10 10MG (10)

11 10MG;10MG (1)

12 12.5MG (1)

13 125MG (1)

14 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

15 125MG/ML (1)

16 150MG (1)

17 15MEQ (1)

18 15MG (1)

19 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS (1)

20 1MCG (1)

21 1MG (1)

22 1MG/ML (1)

23 2% (1)

24 2.5MG (1)

25 2.5MG/ML (1)

26 200MG (5)

27 20MG (4)

28 250MG (3)

29 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

30 250MG;125MG (1)

31 25MG (4)

32 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT (1)

33 2MCG (1)

34 2MG (3)

35 2MG/5ML;10MG/5ML;30MG/5ML (1)

36 2MG;125MG (1)

37 300MG (2)

38 300MG/5ML (1)

39 30MG (3)

40 40MG/ML (1)

41 450MG (1)

42 4MCG (1)

43 4MG (1)

44 50,000 IU (1)

45 500MG (1)

46 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

47 50MG (2)

48 5MG (8)

49 5MG/5ML (1)

50 625MG (1)

51 6MG (1)

52 750MG/5ML (1)

53 75MG (1)

54 800MG/PACKET (1)

55 EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) (1)

56 EQ 0.5MG BASE (1)

57 EQ 10MG BASE (2)

58 EQ 1MG BASE (1)

59 EQ 1MG BASE/ML (EQ 1MG BASE/ML) (1)

60 EQ 200MG BASE (1)

61 EQ 200MG FREE ACID AND POTASSIUM SALT (1)

62 EQ 250MG BASE (1)

63 EQ 2MG BASE (1)

64 EQ 4MG BASE/4ML (EQ 1MG BASE/ML) (1)

65 EQ 500MG BASE (1)

66 EQ 5MG BASE (2)

67 EQ 600MG BASE (1)

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01 DISCN (10)

02 OTC (13)

03 RX (87)

URL Supplier Web Content
TABLET; ORAL
250MG;125MG
2023-08-01
216999
ACETAMINOPHEN AND ...
OTC
No
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CAPSULE; ORAL
100MG
2008-05-29
78720
AMANTADINE HYDROCH...
RX
No
AB
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TABLET; ORAL
5MG
2019-11-22
212919
AMPHETAMINE SULFAT...
RX
No
AA
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TABLET; ORAL
10MG
2019-11-22
212919
AMPHETAMINE SULFAT...
RX
No
AA
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TABLET; ORAL
2.5MG
2020-04-08
210152
APIXABAN
DISCN
No
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TABLET; ORAL
5MG
2020-04-08
210152
APIXABAN
DISCN
No
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SUSPENSION; ORAL
750MG/5ML
2021-03-30
212918
ATOVAQUONE
RX
No
AB
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SPRAY, METERED; NA...
0.137MG/SPRAY
2015-07-28
90176
AZELASTINE HYDROCH...
RX
No
AB
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TABLET; ORAL
EQ 600MG BASE
2018-12-26
209999
AZITHROMYCIN
RX
No
AB
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TABLET; ORAL
EQ 250MG BASE
2019-02-26
210000
AZITHROMYCIN
RX
No
AB
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