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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088616
Company: ACTAVIS LABS UT INC
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 Yes 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
11/09/1984 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
12/10/2014 SUPPL-64 Labeling-Package Insert

Label is not available on this site.

06/23/2011 SUPPL-62 Labeling-Package Insert

Label is not available on this site.

03/06/2002 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

08/15/2001 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

07/30/2001 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

07/18/2002 SUPPL-41 Labeling

Label is not available on this site.

07/26/1999 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

07/01/1999 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

07/01/1999 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

07/01/1999 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

10/16/1998 SUPPL-36 Labeling

Label is not available on this site.

11/20/1996 SUPPL-35 Labeling

Label is not available on this site.

04/23/1996 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

02/20/1998 SUPPL-33 Labeling

Label is not available on this site.

08/04/1995 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

02/16/1995 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

09/27/1993 SUPPL-29 Labeling

Label is not available on this site.

08/20/1993 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

04/16/1992 SUPPL-27 Labeling

Label is not available on this site.

01/30/1992 SUPPL-26 Labeling

Label is not available on this site.

12/17/1991 SUPPL-25 Labeling

Label is not available on this site.

05/26/1992 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

10/03/1991 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

08/05/1991 SUPPL-22 Labeling

Label is not available on this site.

09/11/1990 SUPPL-21 Labeling

Label is not available on this site.

08/24/1990 SUPPL-20 Labeling

Label is not available on this site.

05/10/1990 SUPPL-18 Labeling

Label is not available on this site.

03/21/1990 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

03/21/1990 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

08/05/1991 SUPPL-14 Labeling

Label is not available on this site.

05/15/1989 SUPPL-13 Labeling

Label is not available on this site.

03/21/1990 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

03/21/1990 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

10/18/1988 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

06/19/1986 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

06/19/1986 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

06/19/1986 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

06/19/1986 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/19/1985 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

07/19/1985 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/30/1985 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/19/1985 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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