Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016709
Company: ORTHO MCNEIL JANSSEN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ORTHO-NOVUM 1/50 28 MESTRANOL; NORETHINDRONE 0.05MG;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
08/21/1968 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
06/03/2002 SUPPL-128 Manufacturing (CMC)-Control

Label is not available on this site.

06/05/2000 SUPPL-126 Labeling

Label is not available on this site.

01/05/2000 SUPPL-125 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/28/1998 SUPPL-124 Manufacturing (CMC)

Label is not available on this site.

07/10/1998 SUPPL-123 Labeling

Label is not available on this site.

11/28/1997 SUPPL-122 Labeling

Label is not available on this site.

01/29/1997 SUPPL-121 Manufacturing (CMC)-Control

Label is not available on this site.

04/09/1996 SUPPL-120 Manufacturing (CMC)-Control

Label is not available on this site.

11/30/1995 SUPPL-118 Manufacturing (CMC)

Label is not available on this site.

09/07/1995 SUPPL-117 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/1994 SUPPL-116 Manufacturing (CMC)-Control

Label is not available on this site.

07/06/1994 SUPPL-115 Labeling

Label is not available on this site.

11/04/1993 SUPPL-114 Manufacturing (CMC)

Label is not available on this site.

05/18/1993 SUPPL-113 Manufacturing (CMC)-Control

Label is not available on this site.

03/07/1994 SUPPL-112 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/18/1991 SUPPL-110 Manufacturing (CMC)-Control

Label is not available on this site.

09/16/1991 SUPPL-109 Labeling

Label is not available on this site.

01/18/1990 SUPPL-108 Manufacturing (CMC)-Control

Label is not available on this site.

12/27/1996 SUPPL-107 Manufacturing (CMC)-Control

Label is not available on this site.

10/23/1989 SUPPL-106 Labeling

Label is not available on this site.

07/19/1989 SUPPL-105 Labeling

Label is not available on this site.

10/28/1988 SUPPL-104 Manufacturing (CMC)-Control

Label is not available on this site.

06/08/1988 SUPPL-103 Manufacturing (CMC)

Label is not available on this site.

09/09/1988 SUPPL-102 Labeling

Label is not available on this site.

02/26/1987 SUPPL-101 Labeling

Label is not available on this site.

11/23/1987 SUPPL-100 Manufacturing (CMC)-Control

Label is not available on this site.

10/21/1985 SUPPL-98 Labeling

Label is not available on this site.

04/05/1985 SUPPL-97 Labeling

Label is not available on this site.

06/21/1984 SUPPL-96 Labeling

Label is not available on this site.

01/30/1984 SUPPL-95 Labeling

Label is not available on this site.

09/29/1983 SUPPL-94 Labeling

Label is not available on this site.

11/08/1979 SUPPL-84 Manufacturing (CMC)-Control

Label is not available on this site.

08/15/1979 SUPPL-81 Labeling

Label is not available on this site.

10/19/1979 SUPPL-80 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/25/1978 SUPPL-77 Manufacturing (CMC)-Control

Label is not available on this site.

06/26/1978 SUPPL-76 Labeling

Label is not available on this site.

02/28/1978 SUPPL-66 Manufacturing (CMC)-Control

Label is not available on this site.

02/28/1978 SUPPL-65 Manufacturing (CMC)-Control

Label is not available on this site.

02/28/1978 SUPPL-64 Manufacturing (CMC)-Control

Label is not available on this site.

04/17/1978 SUPPL-63 Manufacturing (CMC)-Control

Label is not available on this site.

05/25/1978 SUPPL-60 Manufacturing (CMC)-Control

Label is not available on this site.

03/19/1978 SUPPL-56 Manufacturing (CMC)-Control

Label is not available on this site.

01/18/1978 SUPPL-55 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/18/1978 SUPPL-54 Labeling

Label is not available on this site.

07/25/1978 SUPPL-53 Manufacturing (CMC)-Control

Label is not available on this site.

07/01/1977 SUPPL-52 Labeling

Label is not available on this site.

04/10/1979 SUPPL-49 Labeling

Label is not available on this site.

08/09/1976 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

08/09/1976 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/1975 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/1975 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/1975 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/1975 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/1975 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/1975 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

05/21/1975 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

05/21/1975 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

05/21/1975 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

05/21/1975 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

03/06/1975 SUPPL-21 Unspecified

Label is not available on this site.

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