Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 008720
Company: VALEANT PHARM INTL

Products on NDA 008720

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEVO-DROMORAN	LEVORPHANOL TARTRATE	2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 008720

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/08/1953	ORIG-1	Approval	Type 3 - New Dosage Form	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
09/03/2004	SUPPL-16	Manufacturing (CMC)	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/08720s016ltr.pdf
01/26/1998	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
02/25/1986	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
02/03/1983	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
03/03/1981	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
06/25/1979	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
02/07/1978	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
12/19/1991	SUPPL-6	Efficacy-New Indication		Label is not available on this site.