Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075929
Company: VINTAGE PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 325MG;50MG;40MG;30MG CAPSULE;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/22/2002 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/18/2018 SUPPL-24 REMS - PROPOSAL - D-N-A

Label is not available on this site.

08/04/2014 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

08/15/2013 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

11/29/2011 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

09/19/2008 SUPPL-5 Labeling

Label is not available on this site.

02/15/2008 SUPPL-4 Labeling

Label is not available on this site.

10/25/2007 SUPPL-3 Labeling

Label is not available on this site.

BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE

CAPSULE;ORAL; 325MG;50MG;40MG;30MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 325MG;50MG;40MG;30MG CAPSULE;ORAL Prescription No AB 076560 NEXGEN PHARMA INC
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 325MG;50MG;40MG;30MG CAPSULE;ORAL Prescription No AB 204649 STRIDES PHARMA
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 325MG;50MG;40MG;30MG CAPSULE;ORAL Prescription No AB 075929 VINTAGE PHARMS
FIORICET W/ CODEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 325MG;50MG;40MG;30MG CAPSULE;ORAL Prescription Yes AB 020232 ACTAVIS LABS UT INC

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