Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016954
Company: JANSSEN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MICRONOR NORETHINDRONE 0.35MG 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
01/02/1973 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
09/11/2014 SUPPL-107 Manufacturing (CMC)

Label is not available on this site.

06/18/2014 SUPPL-106 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016954s106lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016954Orig1s106ltr.pdf
06/20/2008 SUPPL-101 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016954s101lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016954s101ltr.pdf
10/01/2003 SUPPL-92 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16954slr092ltr.pdf
06/20/2002 SUPPL-91 Manufacturing (CMC)

Label is not available on this site.

05/24/2000 SUPPL-90 Manufacturing (CMC)-Control

Label is not available on this site.

05/23/2000 SUPPL-89 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.

04/28/1998 SUPPL-87 Manufacturing (CMC)

Label is not available on this site.

04/13/1998 SUPPL-86 Manufacturing (CMC)

Label is not available on this site.

11/10/1999 SUPPL-85 Labeling

Label is not available on this site.

01/14/1997 SUPPL-84 Manufacturing (CMC)-Control

Label is not available on this site.

03/14/1996 SUPPL-83 Labeling

Label is not available on this site.

04/09/1996 SUPPL-82 Manufacturing (CMC)-Control

Label is not available on this site.

11/30/1995 SUPPL-81 Manufacturing (CMC)

Label is not available on this site.

09/07/1995 SUPPL-80 Manufacturing (CMC)-Control

Label is not available on this site.

06/28/1994 SUPPL-79 Labeling

Label is not available on this site.

11/04/1993 SUPPL-78 Manufacturing (CMC)

Label is not available on this site.

05/18/1993 SUPPL-77 Manufacturing (CMC)-Control

Label is not available on this site.

07/26/1990 SUPPL-75 Manufacturing (CMC)-Control

Label is not available on this site.

09/16/1991 SUPPL-74 Labeling

Label is not available on this site.

01/18/1990 SUPPL-73 Manufacturing (CMC)-Control

Label is not available on this site.

10/23/1989 SUPPL-72 Labeling

Label is not available on this site.

07/19/1989 SUPPL-71 Labeling

Label is not available on this site.

10/28/1988 SUPPL-70 Manufacturing (CMC)-Control

Label is not available on this site.

09/09/1988 SUPPL-69 Labeling

Label is not available on this site.

02/26/1987 SUPPL-68 Labeling

Label is not available on this site.

11/23/1987 SUPPL-67 Manufacturing (CMC)-Control

Label is not available on this site.

10/21/1985 SUPPL-65 Labeling

Label is not available on this site.

04/05/1985 SUPPL-63 Labeling

Label is not available on this site.

06/21/1984 SUPPL-62 Manufacturing (CMC)-Control

Label is not available on this site.

01/30/1984 SUPPL-61 Labeling

Label is not available on this site.

09/29/1983 SUPPL-60 Labeling

Label is not available on this site.

06/15/1983 SUPPL-59 Labeling

Label is not available on this site.

06/09/1983 SUPPL-58 Manufacturing (CMC)-Control

Label is not available on this site.

09/29/1982 SUPPL-56 Labeling

Label is not available on this site.

11/20/1980 SUPPL-53 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/1980 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

03/24/1980 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

11/08/1979 SUPPL-49 Manufacturing (CMC)-Control

Label is not available on this site.

08/15/1979 SUPPL-47 Labeling

Label is not available on this site.

10/19/1979 SUPPL-46 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/19/1978 SUPPL-44 Labeling

Label is not available on this site.

06/21/1979 SUPPL-39 Unspecified

Label is not available on this site.

09/25/1978 SUPPL-36 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/17/1978 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

05/25/1978 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

03/29/1978 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

05/18/1976 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

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

Label is not available on this site.

05/18/1976 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/1975 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/1975 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/1975 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/1975 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/1975 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/1975 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

05/21/1975 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

05/21/1975 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

05/21/1975 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

05/21/1975 SUPPL-6 Unspecified

Label is not available on this site.

03/06/1975 SUPPL-5 Unspecified

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/18/2014 SUPPL-106 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016954s106lbl.pdf
06/20/2008 SUPPL-101 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016954s101lbl.pdf

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