Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 012728
Company: ORTHO MCNEIL PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ORTHO-NOVUM 1/50 21 MESTRANOL; NORETHINDRONE 0.05MG;1MG TABLET;ORAL-21 Discontinued None No No
ORTHO-NOVUM 10-21 MESTRANOL; NORETHINDRONE 0.06MG;10MG TABLET;ORAL-21 Discontinued None No No
ORTHO-NOVUM 2-21 MESTRANOL; NORETHINDRONE 0.1MG;2MG TABLET;ORAL-21 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
05/21/1962 ORIG-1 Approval Type 4 - New Combination 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
01/05/2000 SUPPL-190 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/28/1998 SUPPL-189 Manufacturing (CMC)

Label is not available on this site.

07/10/1998 SUPPL-188 Labeling

Label is not available on this site.

01/29/1997 SUPPL-186 Manufacturing (CMC)-Control

Label is not available on this site.

04/09/1996 SUPPL-185 Manufacturing (CMC)-Control

Label is not available on this site.

11/30/1995 SUPPL-183 Manufacturing (CMC)

Label is not available on this site.

09/07/1995 SUPPL-182 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/1994 SUPPL-181 Manufacturing (CMC)-Control

Label is not available on this site.

06/28/1994 SUPPL-180 Labeling

Label is not available on this site.

11/04/1993 SUPPL-179 Manufacturing (CMC)

Label is not available on this site.

05/18/1993 SUPPL-178 Manufacturing (CMC)-Control

Label is not available on this site.

03/07/1994 SUPPL-177 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/18/1991 SUPPL-175 Manufacturing (CMC)-Control

Label is not available on this site.

09/16/1991 SUPPL-174 Labeling

Label is not available on this site.

12/27/1996 SUPPL-173 Manufacturing (CMC)-Control

Label is not available on this site.

10/23/1989 SUPPL-172 Labeling

Label is not available on this site.

07/19/1989 SUPPL-171 Labeling

Label is not available on this site.

10/28/1988 SUPPL-170 Manufacturing (CMC)-Control

Label is not available on this site.

06/08/1988 SUPPL-169 Manufacturing (CMC)

Label is not available on this site.

09/09/1988 SUPPL-166 Labeling

Label is not available on this site.

02/26/1987 SUPPL-165 Labeling

Label is not available on this site.

11/23/1987 SUPPL-164 Manufacturing (CMC)-Control

Label is not available on this site.

10/21/1985 SUPPL-162 Labeling

Label is not available on this site.

04/05/1985 SUPPL-161 Labeling

Label is not available on this site.

06/21/1984 SUPPL-160 Labeling

Label is not available on this site.

01/30/1984 SUPPL-159 Labeling

Label is not available on this site.

09/29/1983 SUPPL-158 Labeling

Label is not available on this site.

09/14/1978 SUPPL-105 Labeling

Label is not available on this site.

03/29/1978 SUPPL-87 Unspecified

Label is not available on this site.

07/25/1978 SUPPL-86 Manufacturing (CMC)-Control

Label is not available on this site.

10/20/1977 SUPPL-85 Labeling

Label is not available on this site.

07/01/1977 SUPPL-84 Labeling

Label is not available on this site.

08/06/1976 SUPPL-73 Manufacturing (CMC)-Control

Label is not available on this site.

08/06/1976 SUPPL-72 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/1975 SUPPL-64 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/1975 SUPPL-63 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/1975 SUPPL-62 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/1975 SUPPL-61 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/1975 SUPPL-60 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/1975 SUPPL-59 Manufacturing (CMC)-Control

Label is not available on this site.

05/21/1975 SUPPL-56 Unspecified

Label is not available on this site.

05/21/1975 SUPPL-55 Manufacturing (CMC)-Control

Label is not available on this site.

05/21/1975 SUPPL-52 Manufacturing (CMC)-Control

Label is not available on this site.

05/21/1975 SUPPL-51 Manufacturing (CMC)-Control

Label is not available on this site.

03/03/1975 SUPPL-50 Unspecified

Label is not available on this site.

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