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

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01 3ALLERGAN

02 7LGM PHARMA

03 4DR 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 3ALVOGEN

13 1AUROLIFE PHARMA LLC

14 1DUNHALL

15 2FOREST PHARMS

16 1FOSUN PHARMA

17 2GILBERT LABS

18 3GRAHAM DM

19 2HALSEY

20 6HIKMA

21 2HIKMA INTL PHARMS

22 1HIKMA PHARMS

23 1IVAX PHARMS

24 1KEY THERAP

25 1LANNETT

26 3LANNETT CO INC

27 2LARKEN LABS INC

28 5MALLINCKRODT

29 1MAYRAND

30 1MIRROR PHARMS LLC

31 1NE RX PHARMA

32 1NESHER PHARMS

33 2NOSTRUM LABS INC

34 1NOVAST LABS

35 1NUVO PHARMS INC

36 1PURACAP PHARM

37 5QUAGEN

38 1QUANTUM PHARMICS

39 1SANDOZ

40 1SAVAGE LABS

41 5SENORES PHARMS

42 1SHIRE

43 1SPECGX LLC

44 1STEVENS J

45 1SUN PHARM INDUSTRIES

46 1US CHEM

47 3VALEANT

48 1VINTAGE PHARMS

49 6WATSON LABS

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PharmaCompass

01

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AAPS 2024
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Dosage Strength : 325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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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AAPS 2024
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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AAPS 2024
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