Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018418
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDERGINE ERGOLOID MESYLATES 1MG/ML SOLUTION;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
01/30/1981 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
05/10/2000 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

11/12/1998 SUPPL-17 Labeling

Label is not available on this site.

02/28/1994 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

05/26/1987 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

04/27/1987 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/13/1984 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/26/1983 SUPPL-7 Labeling

Label is not available on this site.

02/03/1983 SUPPL-4 Labeling

Label is not available on this site.

03/24/1983 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/23/1982 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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