Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018687
Company: SCHERING
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORMODYNE LABETALOL HYDROCHLORIDE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
NORMODYNE LABETALOL HYDROCHLORIDE 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
NORMODYNE LABETALOL HYDROCHLORIDE 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
NORMODYNE LABETALOL HYDROCHLORIDE 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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 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
12/22/2000 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

10/27/2000 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

04/25/2000 SUPPL-21 Labeling

Label is not available on this site.

01/27/2000 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

05/28/1993 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

01/27/1993 SUPPL-18 Manufacturing (CMC)-Packaging

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.

06/16/1989 SUPPL-14 Labeling

Label is not available on this site.

11/22/1988 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

06/16/1989 SUPPL-12 Labeling

Label is not available on this site.

02/23/1989 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/14/1988 SUPPL-10 Labeling

Label is not available on this site.

02/05/1987 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/31/1987 SUPPL-8 Labeling

Label is not available on this site.

08/08/1986 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

01/14/1986 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

08/31/1987 SUPPL-5 Labeling

Label is not available on this site.

06/28/1985 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

08/31/1987 SUPPL-2 Labeling

Label is not available on this site.

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