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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089175
Company: MIKART
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325MG;50MG;40MG TABLET;ORAL Prescription AA 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
01/21/1987 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
10/18/2013 SUPPL-45 Labeling-Package Insert

Label is not available on this site.

06/22/2011 SUPPL-44 Labeling-Package Insert

Label is not available on this site.

06/22/2009 SUPPL-42 Labeling

Label is not available on this site.

11/20/2002 SUPPL-35 Labeling

Label is not available on this site.

08/13/2002 SUPPL-34 Manufacturing (CMC)-Facility

Label is not available on this site.

03/28/2001 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

06/26/1998 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

07/31/1998 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

01/15/1997 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

01/15/1997 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

06/27/1997 SUPPL-28 Labeling

Label is not available on this site.

06/27/1997 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

06/27/1997 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

06/27/1997 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

06/27/1997 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

10/16/1995 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

10/16/1995 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

08/18/1995 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

03/25/1996 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

03/25/1996 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

02/08/1995 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

11/17/1993 SUPPL-17 Labeling

Label is not available on this site.

11/17/1993 SUPPL-16 Labeling

Label is not available on this site.

11/17/1993 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

01/31/1992 SUPPL-13 Labeling

Label is not available on this site.

07/14/1989 SUPPL-12 Labeling

Label is not available on this site.

07/14/1989 SUPPL-11 Labeling

Label is not available on this site.

06/02/1989 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

12/30/1988 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/02/1991 SUPPL-8 Labeling

Label is not available on this site.

08/02/1991 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/12/1988 SUPPL-6 Labeling

Label is not available on this site.

05/20/1988 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/20/1988 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/20/1988 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/20/1988 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/02/1987 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

TABLET;ORAL; 325MG;50MG;40MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325MG;50MG;40MG TABLET;ORAL Prescription No AA 211106 ABHAI LLC
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325MG;50MG;40MG TABLET;ORAL Prescription Yes AA 088616 ACTAVIS LABS UT INC
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325MG;50MG;40MG TABLET;ORAL Prescription No AA 204984 ALVOGEN
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325MG;50MG;40MG TABLET;ORAL Prescription No AA 040864 GRANULES
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325MG;50MG;40MG TABLET;ORAL Prescription No AA 200243 LANNETT CO INC
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325MG;50MG;40MG TABLET;ORAL Prescription No AA 209587 LGM PHARMA
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325MG;50MG;40MG TABLET;ORAL Prescription No AA 089175 MIKART
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325MG;50MG;40MG TABLET;ORAL Prescription No AA 040511 STRIDES PHARMA
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325MG;50MG;40MG TABLET;ORAL Prescription No AA 203647 STRIDES PHARMA
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