Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017489
Company: ORTHO MCNEIL PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ORTHO-NOVUM 1/35-21 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL-21 Discontinued None No No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
10/15/1974 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
02/21/2002 SUPPL-91 Manufacturing (CMC)

Label is not available on this site.

07/09/2001 SUPPL-90 Manufacturing (CMC)-Control

Label is not available on this site.

01/05/2000 SUPPL-88 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/27/1999 SUPPL-87 Labeling

Label is not available on this site.

04/28/1998 SUPPL-86 Manufacturing (CMC)

Label is not available on this site.

04/13/1998 SUPPL-85 Manufacturing (CMC)

Label is not available on this site.

08/27/1999 SUPPL-84 Labeling

Label is not available on this site.

02/24/1997 SUPPL-83 Manufacturing (CMC)-Control

Label is not available on this site.

01/29/1997 SUPPL-82 Manufacturing (CMC)-Control

Label is not available on this site.

04/09/1996 SUPPL-81 Manufacturing (CMC)-Control

Label is not available on this site.

05/10/1996 SUPPL-80 Manufacturing (CMC)-Control

Label is not available on this site.

11/30/1995 SUPPL-79 Manufacturing (CMC)

Label is not available on this site.

09/07/1995 SUPPL-78 Manufacturing (CMC)-Control

Label is not available on this site.

02/16/1995 SUPPL-77 Manufacturing (CMC)-Control

Label is not available on this site.

06/28/1994 SUPPL-76 Labeling

Label is not available on this site.

11/04/1993 SUPPL-75 Manufacturing (CMC)

Label is not available on this site.

05/18/1993 SUPPL-74 Manufacturing (CMC)-Control

Label is not available on this site.

03/07/1994 SUPPL-73 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/18/1991 SUPPL-71 Manufacturing (CMC)-Control

Label is not available on this site.

09/16/1991 SUPPL-70 Labeling

Label is not available on this site.

10/23/1989 SUPPL-68 Labeling

Label is not available on this site.

07/19/1989 SUPPL-67 Labeling

Label is not available on this site.

10/28/1988 SUPPL-66 Manufacturing (CMC)-Control

Label is not available on this site.

06/08/1988 SUPPL-65 Manufacturing (CMC)

Label is not available on this site.

09/08/1988 SUPPL-64 Labeling

Label is not available on this site.

02/26/1987 SUPPL-63 Labeling

Label is not available on this site.

11/23/1987 SUPPL-62 Manufacturing (CMC)-Control

Label is not available on this site.

10/21/1985 SUPPL-60 Labeling

Label is not available on this site.

04/05/1985 SUPPL-59 Labeling

Label is not available on this site.

06/21/1984 SUPPL-58 Labeling

Label is not available on this site.

01/30/1984 SUPPL-57 Labeling

Label is not available on this site.

09/29/1983 SUPPL-56 Labeling

Label is not available on this site.

06/15/1983 SUPPL-54 Labeling

Label is not available on this site.

06/09/1983 SUPPL-53 Manufacturing (CMC)-Control

Label is not available on this site.

11/20/1980 SUPPL-49 Manufacturing (CMC)-Control

Label is not available on this site.

11/20/1980 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/1980 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

03/24/1980 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

12/05/1979 SUPPL-44 Labeling

Label is not available on this site.

12/05/1979 SUPPL-43 Labeling

Label is not available on this site.

11/08/1979 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

06/19/1979 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

10/19/1979 SUPPL-39 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/24/1980 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

04/17/1978 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

05/25/1978 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

10/20/1977 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

03/29/1978 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1978 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

07/12/1977 SUPPL-22 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/12/1977 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/06/1977 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

05/18/1976 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

05/18/1976 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

05/18/1976 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

05/18/1976 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/1975 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/1975 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/1975 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/1975 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/1975 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/1975 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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