Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019004
Company: ORTHO MCNEIL PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ORTHO-NOVUM 7/14-21 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG,0.035MG;0.5MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL-21 Discontinued None No No
ORTHO-NOVUM 7/14-28 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG,0.035MG;0.5MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL-28 Discontinued None No No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
04/04/1984 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
06/03/2002 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

02/21/2002 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

07/09/2001 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

04/28/1998 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

04/13/1998 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

01/29/1997 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

02/24/1997 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

05/10/1996 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

11/30/1995 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

09/07/1995 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

02/16/1995 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

06/29/1994 SUPPL-17 Labeling

Label is not available on this site.

11/04/1993 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

05/18/1993 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

03/07/1994 SUPPL-14 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/18/1991 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

09/23/1991 SUPPL-11 Labeling

Label is not available on this site.

09/16/1991 SUPPL-10 Labeling

Label is not available on this site.

01/16/1990 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/18/1990 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

02/14/1989 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

02/14/1989 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/14/1989 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/17/1989 SUPPL-2 Labeling

Label is not available on this site.

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