Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089007
Company: MAYNE PHARMA 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 CAPSULE;ORAL Prescription AA No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/17/1986 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-44 Labeling-Package Insert

Label is not available on this site.

06/22/2011 SUPPL-43 Labeling-Package Insert

Label is not available on this site.

05/08/2003 SUPPL-38 Labeling

Label is not available on this site.

08/13/2002 SUPPL-37 Manufacturing (CMC)-Facility

Label is not available on this site.

03/28/2001 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

07/31/1998 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

04/06/1998 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

04/06/1998 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

04/06/1998 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

03/23/2001 SUPPL-31 Labeling

Label is not available on this site.

04/06/1998 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

03/22/1996 SUPPL-29 Labeling

Label is not available on this site.

09/15/1995 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

02/08/1995 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

10/15/1993 SUPPL-26 Labeling

Label is not available on this site.

12/03/1991 SUPPL-24 Labeling

Label is not available on this site.

12/31/1990 SUPPL-23 Labeling

Label is not available on this site.

12/31/1990 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

12/31/1990 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

12/31/1990 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

04/14/1989 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

11/03/1988 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

11/03/1988 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

10/26/1988 SUPPL-16 Labeling

Label is not available on this site.

10/26/1988 SUPPL-15 Labeling

Label is not available on this site.

09/20/1988 SUPPL-14 Labeling

Label is not available on this site.

03/29/1988 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/04/1992 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

06/02/1987 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

11/03/1988 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

03/29/1988 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/29/1988 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/29/1988 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

03/29/1988 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/29/1988 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/29/1988 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/19/1986 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/19/1986 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

CAPSULE;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 CAPSULE;ORAL Prescription No AA 204733 AUROLIFE PHARMA LLC
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325MG;50MG;40MG CAPSULE;ORAL Prescription No AA 212083 LANNETT CO INC
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325MG;50MG;40MG CAPSULE;ORAL Prescription No AA 089007 MAYNE PHARMA INC
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325MG;50MG;40MG CAPSULE;ORAL Prescription No AA 214087 SENORES PHARMS

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