Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018686
Company: SCHERING
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORMODYNE LABETALOL HYDROCHLORIDE 5MG/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
08/01/1984 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
11/06/2001 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

06/05/2001 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

11/16/2000 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

04/25/2000 SUPPL-26 Labeling

Label is not available on this site.

08/10/1999 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

04/29/1999 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

11/14/1997 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

07/09/1997 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

11/25/1996 SUPPL-21 Labeling

Label is not available on this site.

11/07/1996 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

01/12/1995 SUPPL-19 Labeling

Label is not available on this site.

05/28/1993 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

09/16/1991 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

10/15/1992 SUPPL-16 Labeling

Label is not available on this site.

11/07/1990 SUPPL-15 Labeling

Label is not available on this site.

10/19/1989 SUPPL-13 Labeling

Label is not available on this site.

07/21/1989 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/22/1988 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

10/19/1989 SUPPL-10 Labeling

Label is not available on this site.

04/14/1988 SUPPL-9 Labeling

Label is not available on this site.

06/12/1987 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

02/05/1987 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/31/1987 SUPPL-6 Labeling

Label is not available on this site.

08/31/1987 SUPPL-5 Labeling

Label is not available on this site.

08/29/1986 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/08/1986 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

01/14/1986 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

04/04/1986 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

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