Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012885
Company: LUNDBECK INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
WINSTROL STANOZOLOL 2MG TABLET;ORAL 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
01/09/1962 ORIG-1 Approval Type 1 - New Molecular Entity 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
11/17/2003 SUPPL-37 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/12885slr037ltr.pdf
02/27/1992 SUPPL-36 Labeling

Label is not available on this site.

12/13/1991 SUPPL-35 Labeling

Label is not available on this site.

04/07/1994 SUPPL-34 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/18/1988 SUPPL-33 Labeling

Label is not available on this site.

02/24/1987 SUPPL-32 Labeling

Label is not available on this site.

03/10/1987 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

05/07/1986 SUPPL-30 Labeling

Label is not available on this site.

05/14/1984 SUPPL-25 Efficacy

Label is not available on this site.

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