Drugs@FDA: FDA-Approved Drugs

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

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.

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.