Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018354
Company: ORTHO MCNEIL JANSSEN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ORTHO-NOVUM 10/11-21 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NORETHINDRONE 0.035MG,0.035MG;0.5MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL-21 Discontinued None Yes No
ORTHO-NOVUM 10/11-28 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG,0.035MG;0.5MG,1MG TABLET;ORAL-28 Discontinued None Yes 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
01/11/1982 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-43 Manufacturing (CMC)-Control

Label is not available on this site.

02/21/2002 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

07/09/2001 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

03/13/2009 SUPPL-40 Labeling

Label is not available on this site.

01/05/2000 SUPPL-39 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/21/2000 SUPPL-38 Labeling

Label is not available on this site.

08/27/1999 SUPPL-37 Labeling

Label is not available on this site.

04/28/1998 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

04/13/1998 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

08/27/1999 SUPPL-34 Labeling

Label is not available on this site.

01/29/1997 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

02/24/1997 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

04/09/1996 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

05/10/1996 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

11/30/1995 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

09/07/1995 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

02/16/1995 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

07/06/1994 SUPPL-26 Labeling

Label is not available on this site.

11/04/1993 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

05/18/1993 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

03/07/1994 SUPPL-23 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/18/1991 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

09/16/1991 SUPPL-20 Labeling

Label is not available on this site.

01/18/1990 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

10/23/1989 SUPPL-17 Labeling

Label is not available on this site.

07/19/1989 SUPPL-16 Labeling

Label is not available on this site.

10/28/1988 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

06/08/1988 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

09/09/1988 SUPPL-13 Labeling

Label is not available on this site.

02/26/1987 SUPPL-12 Labeling

Label is not available on this site.

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

Label is not available on this site.

03/13/2009 SUPPL-10 Labeling

Label is not available on this site.

10/21/1985 SUPPL-9 Labeling

Label is not available on this site.

04/05/1985 SUPPL-8 Labeling

Label is not available on this site.

06/21/1984 SUPPL-7 Labeling

Label is not available on this site.

01/30/1984 SUPPL-6 Labeling

Label is not available on this site.

09/29/1983 SUPPL-5 Labeling

Label is not available on this site.

06/15/1983 SUPPL-3 Labeling

Label is not available on this site.

06/09/1983 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

03/13/2009 SUPPL-1 Labeling

Label is not available on this site.

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