Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018706
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDERGINE LC ERGOLOID MESYLATES 1MG CAPSULE;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
01/18/1983 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
04/03/2001 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

03/09/2001 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

05/10/2000 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

08/18/1999 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

04/21/1999 SUPPL-22 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/07/1995 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

06/16/1994 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

11/12/1998 SUPPL-19 Labeling

Label is not available on this site.

04/15/1993 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

09/02/1993 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/28/1994 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

11/07/1989 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/09/1989 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/26/1987 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

05/03/1985 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/20/1983 SUPPL-5 Labeling

Label is not available on this site.

06/26/1986 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

04/07/1983 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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