Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 009087
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDERGINE ERGOLOID MESYLATES 1MG TABLET;SUBLINGUAL Discontinued None No No
HYDERGINE ERGOLOID MESYLATES 0.5MG TABLET;SUBLINGUAL 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
11/05/1953 ORIG-1 Approval Type 1 - New Molecular Entity 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
05/10/2000 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

04/21/1999 SUPPL-46 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/12/1998 SUPPL-45 Labeling

Label is not available on this site.

09/14/1993 SUPPL-44 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/06/1993 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

11/07/1989 SUPPL-39 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/26/1987 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

10/26/1983 SUPPL-36 Labeling

Label is not available on this site.

08/26/1983 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

02/03/1983 SUPPL-33 Labeling

Label is not available on this site.

01/19/1983 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

08/10/1981 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

09/02/1981 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

01/19/1981 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/24/1981 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

12/11/1979 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

06/14/1979 SUPPL-25 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/04/1981 SUPPL-24 Labeling

Label is not available on this site.

07/13/1978 SUPPL-22 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/16/1978 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

06/27/1978 SUPPL-20 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/14/1978 SUPPL-19 Labeling

Label is not available on this site.

03/20/1978 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/28/1976 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/30/1976 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/23/1976 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

11/13/1975 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

10/06/1975 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

06/25/1975 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

06/02/1975 SUPPL-6 Efficacy

Label is not available on this site.

12/13/1974 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

04/16/1975 SUPPL-4 Unspecified

Label is not available on this site.

06/25/1974 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

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