Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017557
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DANOCRINE DANAZOL 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None No No
DANOCRINE DANAZOL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None No No
DANOCRINE DANAZOL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None No No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
06/21/1976 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/20/2011 SUPPL-42 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017557s033s039s040s041s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017557s033,s039,s040,s041,s042ltr.pdf
12/20/2011 SUPPL-41 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017557s033s039s040s041s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017557s033,s039,s040,s041,s042ltr.pdf
12/20/2011 SUPPL-40 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017557s033s039s040s041s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017557s033,s039,s040,s041,s042ltr.pdf
12/20/2011 SUPPL-39 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017557s033s039s040s041s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017557s033,s039,s040,s041,s042ltr.pdf
12/19/1996 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

12/20/2011 SUPPL-33 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017557s033s039s040s041s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017557s033,s039,s040,s041,s042ltr.pdf
05/02/1994 SUPPL-32 Labeling

Label is not available on this site.

01/28/1994 SUPPL-31 Labeling

Label is not available on this site.

08/02/1995 SUPPL-30 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/01/1993 SUPPL-29 Labeling

Label is not available on this site.

07/05/1990 SUPPL-28 Labeling

Label is not available on this site.

05/02/1988 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

03/24/1986 SUPPL-26 Labeling

Label is not available on this site.

01/29/1985 SUPPL-25 Labeling

Label is not available on this site.

08/09/1984 SUPPL-23 Labeling

Label is not available on this site.

08/09/1984 SUPPL-22 Labeling

Label is not available on this site.

08/09/1984 SUPPL-21 Labeling

Label is not available on this site.

01/22/1982 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

11/01/1982 SUPPL-15 Labeling

Label is not available on this site.

11/03/1980 SUPPL-14 Labeling

Label is not available on this site.

05/29/1980 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/03/1980 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

03/31/1980 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/18/1981 SUPPL-10 Efficacy

Label is not available on this site.

10/25/1979 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

09/02/1980 SUPPL-6 Efficacy

Label is not available on this site.

05/31/1978 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/14/1978 SUPPL-4 Labeling

Label is not available on this site.

03/23/1978 SUPPL-3 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/27/1976 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/20/2011 SUPPL-42 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017557s033s039s040s041s042lbl.pdf
12/20/2011 SUPPL-41 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017557s033s039s040s041s042lbl.pdf
12/20/2011 SUPPL-40 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017557s033s039s040s041s042lbl.pdf
12/20/2011 SUPPL-39 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017557s033s039s040s041s042lbl.pdf
12/20/2011 SUPPL-33 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017557s033s039s040s041s042lbl.pdf

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