Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 086710
Company: ACTAVIS ELIZABETH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUTALBITAL, ASPIRIN AND CAFFEINE ASPIRIN; BUTALBITAL; CAFFEINE 325MG;50MG;40MG TABLET;ORAL Discontinued None 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
07/25/1979 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
11/02/2001 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

10/12/1999 SUPPL-45 Labeling

Label is not available on this site.

11/23/1998 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

03/09/1998 SUPPL-43 Labeling

Label is not available on this site.

05/09/1997 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

01/18/1996 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

11/25/1991 SUPPL-40 Labeling

Label is not available on this site.

10/04/1989 SUPPL-39 Labeling

Label is not available on this site.

08/04/1989 SUPPL-38 Labeling

Label is not available on this site.

08/04/1989 SUPPL-37 Labeling

Label is not available on this site.

11/05/1990 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

11/05/1990 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

11/05/1990 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

08/13/1985 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

08/13/1985 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

08/13/1985 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

08/13/1985 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

03/15/1985 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

10/25/1983 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

07/06/1983 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

10/25/1983 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

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