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Approved Drug Products containing Caffeine, Monohydrate listed in the FDA Orange Book. Original Data : FDA Website

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01 3ALLERGAN

02 6LGM PHARMA

03 3DR REDDYS LABS SA

04 1TARO

05 8MIKART

06 5STRIDES PHARMA

07 3GRANULES

08 1ABHAI LLC

09 4ABLE

10 1ACTAVIS ELIZABETH

11 2ACTAVIS LABS UT INC

12 1ALRA

13 1ALVOGEN

14 1AUROBINDO PHARMA LTD

15 1AUROLIFE PHARMA LLC

16 2BAUSCH

17 1BOCA PHARMA LLC

18 1COSETTE

19 1FOREST PHARMS

20 1FOSUN PHARMA

21 2GALT PHARMS

22 2GILBERT LABS

23 3GRAHAM DM

24 1HALEON US HOLDINGS

25 1HALSEY

26 6HIKMA

27 3HIKMA INTL PHARMS

28 1HIKMA PHARMS

29 1IVAX PHARMS

30 1IVAX SUB TEVA PHARMS

31 2KEY THERAP

32 1LANNETT

33 3LANNETT CO INC

34 1LARKEN LABS INC

35 1LEITNER PHARMS

36 3MALLINCKRODT

37 1MIRROR PHARMS LLC

38 1NESHER PHARMS

39 2NOSTRUM LABS INC

40 2NOVARTIS

41 1NOVAST LABS

42 1NUVO PHARMS INC

43 1ORGANON USA INC

44 1PERRIGO

45 1PHARM RES ASSOC

46 1PURACAP PHARM

47 3QUAGEN

48 1QUANTUM PHARMICS

49 8SANDOZ

50 2SENORES PHARMS

51 1SHIRE

52 1SPECGX LLC

53 3STEVENS J

54 2SUN PHARM INDUSTRIES

55 1TEVA

56 1US CHEM

57 1VALEANT

58 1VINTAGE PHARMS

59 6WATSON LABS

60 1WEST-WARD PHARM CORP

61 1WRASER PHARMS LLC

62 2XANODYNE PHARM

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PharmaCompass

01

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Not Confirmed

ASPIRIN; BUTALBITAL; CAFFEINE

Brand Name : FIORINAL

Dosage Form : TABLET;ORAL

Dosage Strength : 325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1986-04-16

Application Number : 17534

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Abbvie CB

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

RLD : No

TE Code : AA

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Brand Name : BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 300MG;50MG;40MG

Approval Date : 2009-11-16

Application Number : 40885

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

LGM Pharma CB

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

RLD : No

TE Code : AA

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Brand Name : BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 325MG;50MG;40MG

Approval Date : 1986-03-17

Application Number : 89007

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

Dr Reddy Company Banner

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAs a CDMO, Mikart offers integrated CDMO services for Solid Dose & Non-sterile Liquid formulations.

RLD : No

TE Code :

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Brand Name : ESGIC-PLUS

Dosage Form : CAPSULE;ORAL

Dosage Strength : 500MG;50MG;40MG

Approval Date : 1996-03-28

Application Number : 40085

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Mikart

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

RLD : No

TE Code : AA

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Brand Name : BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Dosage Form : TABLET;ORAL

Dosage Strength : 325MG;50MG;40MG

Approval Date : 2003-08-27

Application Number : 40511

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

Strides Pharma Science

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

RLD : No

TE Code : AA

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Brand Name : BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Dosage Form : TABLET;ORAL

Dosage Strength : 325MG;50MG;40MG

Approval Date : 2008-12-01

Application Number : 40864

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

Granules India

07

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Formnext Forum
Not Confirmed

ASPIRIN; BUTALBITAL; CAFFEINE

Brand Name : FIORINAL

Dosage Form : CAPSULE;ORAL

Dosage Strength : 325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1986-04-16

Application Number : 17534

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Abbvie CB

08

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Formnext Forum
Not Confirmed

ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

Brand Name : FIORINAL W/CODEINE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 325MG;50MG;40MG;30MG

Approval Date : 1990-10-26

Application Number : 19429

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Abbvie CB

09

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

RLD : No

TE Code : AB

ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

Brand Name : BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 325MG;50MG;40MG;30MG

Approval Date : 2001-11-30

Application Number : 75231

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

LGM Pharma CB

10

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

RLD : No

TE Code : AB

ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

Brand Name : BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 325MG;50MG;40MG;30MG

Approval Date : 2004-06-10

Application Number : 76560

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

LGM Pharma CB