Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016996
Company: SCHERING
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYPERSTAT DIAZOXIDE 15MG/ML INJECTABLE;INJECTION 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
01/22/1973 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/09/2000 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

04/29/1999 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

10/21/1998 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

06/04/1997 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

11/01/1996 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

02/05/1990 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

06/12/1987 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

07/23/1986 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

04/07/1986 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

09/17/1985 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

08/13/1984 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

03/13/2009 SUPPL-12 Labeling

Label is not available on this site.

10/08/1982 SUPPL-11 Labeling

Label is not available on this site.

01/07/1983 SUPPL-10 Labeling

Label is not available on this site.

08/21/1984 SUPPL-9 Efficacy

Label is not available on this site.

01/08/1981 SUPPL-8 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/14/1980 SUPPL-7 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/20/1981 SUPPL-6 Efficacy

Label is not available on this site.

02/04/1980 SUPPL-5 Labeling

Label is not available on this site.

10/20/1986 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

02/04/1980 SUPPL-3 Labeling

Label is not available on this site.

02/04/1980 SUPPL-2 Labeling

Label is not available on this site.

06/30/1978 SUPPL-1 Labeling

Label is not available on this site.

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