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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084294
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CAFERGOT CAFFEINE; ERGOTAMINE TARTRATE 100MG;1MG TABLET;ORAL Discontinued None 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
09/29/1976 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
04/14/2008 SUPPL-83 Labeling

Label is not available on this site.

10/03/2003 SUPPL-75 Labeling

Label is not available on this site.

07/26/1999 SUPPL-72 Manufacturing (CMC)

Label is not available on this site.

01/24/1994 SUPPL-71 Manufacturing (CMC)

Label is not available on this site.

02/03/1987 SUPPL-70 Manufacturing (CMC)

Label is not available on this site.

02/03/1987 SUPPL-69 Manufacturing (CMC)

Label is not available on this site.

02/05/1986 SUPPL-68 Manufacturing (CMC)

Label is not available on this site.

12/17/1984 SUPPL-67 Manufacturing (CMC)

Label is not available on this site.

07/26/1984 SUPPL-66 Manufacturing (CMC)

Label is not available on this site.

10/03/1984 SUPPL-65 Manufacturing (CMC)

Label is not available on this site.

10/03/1984 SUPPL-64 Manufacturing (CMC)

Label is not available on this site.

09/09/1983 SUPPL-63 Manufacturing (CMC)

Label is not available on this site.

07/18/1983 SUPPL-61 Manufacturing (CMC)

Label is not available on this site.

06/06/1983 SUPPL-60 Manufacturing (CMC)

Label is not available on this site.

03/24/1983 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

07/01/1982 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

07/01/1982 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

07/01/1982 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

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