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Approved Drug Products containing Prestwick3_000104 listed in the FDA Orange Book. Original Data : FDA Website

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01 1ABBVIE

02 2ACTAVIS ELIZABETH

03 1AJANTA PHARMA LTD

04 1AKORN

05 2ALEMBIC PHARMS LTD

06 6ALKEM LABS LTD

07 1AMNEALS PHARMS

08 5ANNORA PHARMA

09 3APOTEX

10 1APOTEX INC

11 2APOTHECON

12 5ASCENT PHARMS INC

13 2AUROBINDO PHARMA

14 2AUROBINDO PHARMA LTD

15 2BAUSCH

16 1BAXTER HLTHCARE

17 2CARLSBAD

18 1CARNEGIE

19 1CEROVENE INC

20 2CHARTWELL RX

21 4CONTRACT PHARMACAL

22 4DR REDDYS LABS LTD

23 1ENDO OPERATIONS

24 2EPIC PHARMA LLC

25 2FRESENIUS KABI USA

26 2GLENMARK PHARMS INC

27 2GRAVITI PHARMS

28 4HIKMA

29 1HORIZON

30 4HOSPIRA

31 2IVAX SUB TEVA PHARMS

32 6J AND J CONSUMER INC

33 1LUPIN LTD

34 2MANKIND PHARMA

35 2MARKSANS PHARMA

36 3MARSAM PHARMS LLC

37 4MERCK

38 1MERCK SHARP DOHME

39 1MICRO LABS

40 2MSN

41 2MYLAN LABS LTD

42 2MYLAN PHARMS INC

43 1NATCO PHARMA

44 1NAVINTA LLC

45 1NOVEL LABS INC

46 1NOVITIUM PHARMA

47 1P AND L

48 2PERRIGO

49 5PERRIGO R AND D

50 2RISING

51 2RISING PHARMA

52 4SAGENT

53 1SALIX PHARMS

54 5SANDOZ

55 2SUN PHARM INDS LTD

56 2SUN PHARM INDUSTRIES

57 3TEVA

58 1TEVA PHARMS USA

59 1TORRENT

60 2UCB INC

61 1UPSHER SMITH LABS

62 2VKT PHARMA

63 3WATSON LABS

64 3ZYDUS PHARMS

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PharmaCompass

01

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FAMOTIDINE

Brand Name : FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 0.4MG/ML

Approval Date : 2001-12-17

Application Number : 75729

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Abbvie Company Banner

02

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FAMOTIDINE

Brand Name : PEPCID

Dosage Form : TABLET;ORAL

Dosage Strength : 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1986-10-15

Application Number : 19462

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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03

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FAMOTIDINE

Brand Name : PEPCID

Dosage Form : TABLET;ORAL

Dosage Strength : 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1986-10-15

Application Number : 19462

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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04

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FAMOTIDINE

Brand Name : PEPCID AC

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 1995-04-28

Application Number : 20325

RX/OTC/DISCN : OTC

RLD : Yes

TE Code :

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05

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FAMOTIDINE

Brand Name : PEPCID AC

Dosage Form : TABLET;ORAL

Dosage Strength : 20MG

Approval Date : 2003-09-23

Application Number : 20325

RX/OTC/DISCN : OTC

RLD : Yes

TE Code :

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06

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FAMOTIDINE

Brand Name : PEPCID

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1986-11-04

Application Number : 19510

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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07

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FAMOTIDINE

Brand Name : PEPCID PRESERVATIVE FREE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1986-11-04

Application Number : 19510

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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08

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Not Confirmed

FAMOTIDINE

Brand Name : PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 0.4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1994-02-18

Application Number : 20249

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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09

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FAMOTIDINE

Brand Name : PEPCID RPD

Dosage Form : TABLET, ORALLY DISINTEGRATING;ORAL

Dosage Strength : 20MG

Approval Date : 1998-05-28

Application Number : 20752

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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10

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FAMOTIDINE

Brand Name : PEPCID

Dosage Form : FOR SUSPENSION;ORAL

Dosage Strength : 40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1987-02-02

Application Number : 19527

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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