Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016725
Company: GD SEARLE LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORINYL 1+80 28-DAY MESTRANOL; NORETHINDRONE 0.08MG;1MG TABLET;ORAL-28 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
11/08/1968 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
07/11/1986 SUPPL-108 Labeling

Label is not available on this site.

10/25/1985 SUPPL-107 Labeling

Label is not available on this site.

04/16/1985 SUPPL-106 Labeling

Label is not available on this site.

11/13/1984 SUPPL-104 Manufacturing (CMC)

Label is not available on this site.

09/27/1984 SUPPL-103 Manufacturing (CMC)-Control

Label is not available on this site.

07/30/1984 SUPPL-102 Labeling

Label is not available on this site.

06/12/1984 SUPPL-101 Labeling

Label is not available on this site.

05/07/1984 SUPPL-99 Labeling

Label is not available on this site.

07/26/1983 SUPPL-98 Manufacturing (CMC)-Control

Label is not available on this site.

07/19/1983 SUPPL-97 Manufacturing (CMC)-Control

Label is not available on this site.

07/19/1983 SUPPL-96 Manufacturing (CMC)-Control

Label is not available on this site.

03/06/1984 SUPPL-95 Labeling

Label is not available on this site.

07/26/1983 SUPPL-94 Manufacturing (CMC)-Control

Label is not available on this site.

06/13/1983 SUPPL-93 Manufacturing (CMC)-Control

Label is not available on this site.

07/29/1982 SUPPL-89 Manufacturing (CMC)-Control

Label is not available on this site.

01/11/1982 SUPPL-85 Manufacturing (CMC)-Control

Label is not available on this site.

04/20/1980 SUPPL-79 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/18/1979 SUPPL-78 Manufacturing (CMC)

Label is not available on this site.

07/18/1979 SUPPL-75 Manufacturing (CMC)-Control

Label is not available on this site.

11/06/1978 SUPPL-70 Manufacturing (CMC)-Control

Label is not available on this site.

11/06/1978 SUPPL-69 Manufacturing (CMC)-Control

Label is not available on this site.

05/26/1978 SUPPL-68 Manufacturing (CMC)-Control

Label is not available on this site.

11/22/1977 SUPPL-58 Labeling

Label is not available on this site.

06/14/1977 SUPPL-56 Labeling

Label is not available on this site.

06/14/1977 SUPPL-55 Labeling

Label is not available on this site.

06/14/1977 SUPPL-54 Labeling

Label is not available on this site.

06/14/1977 SUPPL-53 Labeling

Label is not available on this site.

07/01/1977 SUPPL-49 Labeling

Label is not available on this site.

07/01/1977 SUPPL-48 Labeling

Label is not available on this site.

10/14/1980 SUPPL-47 Labeling

Label is not available on this site.

05/16/1975 SUPPL-42 Labeling

Label is not available on this site.

05/16/1975 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/1975 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/1975 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/1975 SUPPL-31 Labeling

Label is not available on this site.

05/16/1975 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

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