Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017993
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDERGINE ERGOLOID MESYLATES 1MG TABLET;ORAL Discontinued None Yes No
HYDERGINE ERGOLOID MESYLATES 0.5MG 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
12/30/1977 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/02/2001 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

08/01/2000 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

05/10/2000 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

03/13/2000 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

06/18/1996 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/1995 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

10/12/1995 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

11/12/1998 SUPPL-27 Labeling

Label is not available on this site.

09/14/1993 SUPPL-26 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/28/1994 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

02/28/1994 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

11/07/1989 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/26/1987 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

02/07/1985 SUPPL-17 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

10/26/1983 SUPPL-16 Labeling

Label is not available on this site.

02/03/1983 SUPPL-14 Labeling

Label is not available on this site.

09/15/1982 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

01/19/1983 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

03/25/1982 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/10/1981 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/02/1981 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

02/03/1981 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/11/1979 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/04/1981 SUPPL-4 Labeling

Label is not available on this site.

04/05/1979 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/01/1979 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/30/1978 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

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