Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 006620
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CAFERGOT CAFFEINE; ERGOTAMINE TARTRATE 100MG;1MG 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
11/26/1948 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
10/12/1995 SUPPL-53 Manufacturing (CMC)-Control

Label is not available on this site.

04/29/1994 SUPPL-51 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/15/1994 SUPPL-49 Manufacturing (CMC)-Control

Label is not available on this site.

04/15/1993 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

06/16/1993 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

03/04/1994 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

02/28/1994 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

11/07/1989 SUPPL-40 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/10/1989 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

01/16/1990 SUPPL-38 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/17/1988 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

11/15/1988 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

11/19/1985 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

03/26/1985 SUPPL-32 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/07/1985 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

11/19/1985 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

03/29/1982 SUPPL-27 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/30/1981 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

08/10/1981 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

08/10/1981 SUPPL-24 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/29/1981 SUPPL-23 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/18/1980 SUPPL-22 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/06/1979 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/31/1979 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/30/1979 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/14/1978 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/31/1977 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/30/1976 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/06/1976 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/21/1976 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

08/12/1975 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

01/09/1975 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

01/09/1975 SUPPL-6 Labeling

Label is not available on this site.

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