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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 086398
Company: FOSUN PHARMA
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
07/30/1980 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
01/13/2000 SUPPL-46 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/28/1996 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

01/09/1992 SUPPL-44 Labeling

Label is not available on this site.

11/09/1990 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

01/01/1990 SUPPL-42 Labeling

Label is not available on this site.

01/15/1988 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

01/23/1987 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

02/06/1987 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

12/19/1984 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

12/19/1984 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

08/06/1984 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

05/24/1984 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

04/27/1984 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

04/06/1984 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

04/06/1984 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

04/06/1984 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

07/01/1983 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

02/14/1983 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

12/17/1982 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

12/17/1982 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

12/17/1982 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

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