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List of All Manufacturers & Suppliers of Prestwick3_000104 Licensing, EU CTD Dossiers, Marketing Authorizations, Finished Dosage Formulations listed on PharmaCompass.com

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01 1AbbVie Inc

02 2Octavius Pharma Pvt. Ltd

03 2ANGITA PHARMA INC.

04 5Actavis Inc

05 6Ajanta Pharma Limited

06 1Akorn Pharmaceuticals

07 2Alembic Pharmaceuticals Limited

08 6Alkem Laboratories

09 1Amneal Pharmaceuticals

10 5Annora Pharma

11 4Apotex Inc

12 2Arrow Pharmaceuticals

13 2Ascent Pharmaceuticals

14 2Atabay

15 4Aurobindo Pharma Limited

16 1B-PHARM Pharmaceutical

17 2Bausch & Lomb Incorporated

18 1Baxter Healthcare Corporation

19 1Bernofarm Pharmaceutical Company

20 2Biofarma Pharmaceutical Industry and Commerce Inc

21 2Bristol Myers Squibb

22 2Carlsbad Technology

23 1Carnegie Pharmaceuticals

24 1Cerovene, Inc

25 2Chartwell Pharmaceuticals llc

26 4Contract Pharmacal Corporation

27 1DelNova Healthcare

28 1EG SpA

29 1ENDO OPERATIONS

30 2Epic Pharma. LLC.

31 2Fresenius Kabi USA

32 1Genchain Biotech

33 2Glenmark Pharmaceuticals

34 2Graviti Pharmaceuticals

35 2Halewood Laboratories Pvt. Ltd

36 4Hikma Pharmaceuticals

37 2Holden Medical Laboratories Pvt. Ltd

38 1Horizon Therapeutics

39 4Hospira, Inc.

40 2IVAX Pharmaceuticals Inc

41 1Igenius Life Sciences

42 2JAMP PHARMA

43 2JW Pharmaceutical Corporation

44 6Johnson & Johnson

45 1Kolmar Korea Co., Ltd.

46 1Lupin Ltd

47 3MARSAM PHARMS LLC

48 2MINT PHARMACEUTICALS INC

49 3MS Pharma

50 2MSN Laboratories

51 2Mankind Pharma

52 2Marksans Pharma

53 1Maxheal Pharmaceuticals (India) Ltd

54 4McNeil Consumer Health

55 6Merck & Co

56 1Micro Labs Limited

57 1Natco Pharma

58 1Navinta

59 1Novel Laboratories, Inc.

60 1Novitium Pharma LLC

61 2Omega Laboratories Limited

62 1PL Developments

63 2PRO.MED.CS Praha

64 1Pantson Pharma Pvt. Limited

65 7Perrigo Company plc

66 3Pluviaendo

67 2RISING PHARMA

68 2Rising Pharmaceuticals Inc

69 2SIGMA TAU

70 4Sagent Pharmaceuticals

71 1Salix Pharmaceuticals

72 5Sandoz B2B

73 4Sun Pharmaceutical Industries Limited

74 6Teva Pharmaceutical Industries

75 1Torrent Pharmaceuticals Limited

76 2UCB Pharma S.A

77 1Upsher-Smith Laboratories

78 2VKT Pharma

79 1Varichem Pharmaceuticals Pvt Ltd

80 4Viatris

81 2World Medicine

82 4XYZ Pharma

83 2Zim Laboratories

84 3Zydus Pharmaceuticals

85 17Blank

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01

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AAPS 2024
Not Confirmed

FAMOTIDINE

Brand Name : FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 0.4MG/ML

Packaging :

Approval Date : 2001-12-17

Application Number : 75729

Regulatory Info : DISCN

Registration Country : USA

Abbvie Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothOctavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

Regulatory Info : DMF Available|FDF Compliance-USP

Registration Country : India

Famotidine

Brand Name :

Dosage Form : DC Granules

Dosage Strength : 20MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : DMF Available|FDF Compliance-USP

Registration Country : India

Octavius Pharma

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothOctavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

Regulatory Info : DMF Available|FDF Compliance-USP

Registration Country : India

Famotidine

Brand Name :

Dosage Form : DC Granules

Dosage Strength : 40MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : DMF Available|FDF Compliance-USP

Registration Country : India

Octavius Pharma

04

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

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**

Packaging :

Approval Date : 1986-10-15

Application Number : 19462

Regulatory Info : DISCN

Registration Country : USA

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05

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

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**

Packaging :

Approval Date : 1986-10-15

Application Number : 19462

Regulatory Info : DISCN

Registration Country : USA

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06

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

FAMOTIDINE; IBUPROFEN

Brand Name : DUEXIS

Dosage Form : TABLET;ORAL

Dosage Strength : 26.6MG;800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 2011-04-23

Application Number : 22519

Regulatory Info : DISCN

Registration Country : USA

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07

AAPS 2024
Not Confirmed
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AAPS 2024
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FAMOTIDINE

Brand Name : PEPCID AC

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 1995-04-28

Application Number : 20325

Regulatory Info : OTC

Registration Country : USA

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08

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

FAMOTIDINE

Brand Name : PEPCID AC

Dosage Form : TABLET;ORAL

Dosage Strength : 20MG

Packaging :

Approval Date : 2003-09-23

Application Number : 20325

Regulatory Info : OTC

Registration Country : USA

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09

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

FAMOTIDINE

Brand Name : PEPCID AC

Dosage Form : TABLET, CHEWABLE;ORAL

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

Packaging :

Approval Date : 1998-09-24

Application Number : 20801

Regulatory Info : DISCN

Registration Country : USA

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10

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

FAMOTIDINE

Brand Name : PEPCID AC

Dosage Form : TABLET, CHEWABLE;ORAL

Dosage Strength : 20MG

Packaging :

Approval Date : 2007-12-17

Application Number : 20801

Regulatory Info : OTC

Registration Country : USA

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11

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

FAMOTIDINE

Brand Name : PEPCID AC

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 1999-08-05

Application Number : 20902

Regulatory Info : OTC

Registration Country : USA

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12

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE

Brand Name : PEPCID COMPLETE

Dosage Form : TABLET, CHEWABLE;ORAL

Dosage Strength : 800MG;10MG;165MG

Packaging :

Approval Date : 2000-10-16

Application Number : 20958

Regulatory Info : OTC

Registration Country : USA

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13

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

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**

Packaging :

Approval Date : 1986-11-04

Application Number : 19510

Regulatory Info : DISCN

Registration Country : USA

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14

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

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**

Packaging :

Approval Date : 1986-11-04

Application Number : 19510

Regulatory Info : DISCN

Registration Country : USA

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15

AAPS 2024
Not Confirmed
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AAPS 2024
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**

Packaging :

Approval Date : 1994-02-18

Application Number : 20249

Regulatory Info : DISCN

Registration Country : USA

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16

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

FAMOTIDINE

Brand Name : PEPCID RPD

Dosage Form : TABLET, ORALLY DISINTEGRATING;ORAL

Dosage Strength : 20MG

Packaging :

Approval Date : 1998-05-28

Application Number : 20752

Regulatory Info : DISCN

Registration Country : USA

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17

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

FAMOTIDINE

Brand Name : PEPCID RPD

Dosage Form : TABLET, ORALLY DISINTEGRATING;ORAL

Dosage Strength : 40MG

Packaging :

Approval Date : 1998-05-28

Application Number : 20752

Regulatory Info : DISCN

Registration Country : USA

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18

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

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**

Packaging :

Approval Date : 1987-02-02

Application Number : 19527

Regulatory Info : DISCN

Registration Country : USA

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19

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

FAMOTIDINE

Brand Name : FLUXID

Dosage Form : TABLET, ORALLY DISINTEGRATING;ORAL

Dosage Strength : 20MG

Packaging :

Approval Date : 2004-09-24

Application Number : 21712

Regulatory Info : DISCN

Registration Country : USA

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AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

FAMOTIDINE

Brand Name : FLUXID

Dosage Form : TABLET, ORALLY DISINTEGRATING;ORAL

Dosage Strength : 40MG

Packaging :

Approval Date : 2004-09-24

Application Number : 21712

Regulatory Info : DISCN

Registration Country : USA

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