Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 008719
Company: VALEANT PHARM INTL

Products on NDA 008719

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEVO-DROMORAN	LEVORPHANOL TARTRATE	2MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 008719

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
12/05/2000	SUPPL-32	Manufacturing (CMC)-Control		Label is not available on this site.
04/24/2000	SUPPL-31	Manufacturing (CMC)-Control		Label is not available on this site.
07/13/1999	SUPPL-30	Manufacturing (CMC)-Control		Label is not available on this site.
01/26/1998	SUPPL-29	Manufacturing (CMC)-Control		Label is not available on this site.
08/15/1994	SUPPL-28	Manufacturing (CMC)-Control		Label is not available on this site.
08/15/1994	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
09/27/1989	SUPPL-26	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/09/1989	SUPPL-25	Manufacturing (CMC)-Formulation		Label is not available on this site.
09/03/1985	SUPPL-24	Manufacturing (CMC)-Control		Label is not available on this site.
10/23/1985	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
02/26/1985	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
06/07/1984	SUPPL-21	Labeling		Label is not available on this site.
09/20/1983	SUPPL-20	Manufacturing (CMC)-Control		Label is not available on this site.
04/19/1983	SUPPL-19	Labeling		Label is not available on this site.
05/16/1983	SUPPL-18	Manufacturing (CMC)-Control		Label is not available on this site.
03/03/1982	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
09/08/1981	SUPPL-16	Manufacturing (CMC)-Packaging		Label is not available on this site.
02/27/1981	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
11/15/1978	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
02/07/1978	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
12/19/1991	SUPPL-8	Efficacy-New Indication		Label is not available on this site.