Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016740
Company: SCHERING

Products on NDA 016740

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VALISONE	BETAMETHASONE VALERATE	EQ 0.1% BASE	OINTMENT;TOPICAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 016740

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/17/1969	ORIG-1	Approval	Type 3 - New Dosage Form	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
11/08/1991	SUPPL-18	Manufacturing (CMC)-Control		Label is not available on this site.
09/12/1986	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
05/20/1986	SUPPL-16	Manufacturing (CMC)-Control		Label is not available on this site.
01/07/1986	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
04/23/1986	SUPPL-14	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
04/16/1982	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
09/15/1981	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
09/15/1981	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
12/22/1982	SUPPL-10	Labeling		Label is not available on this site.
12/26/1979	SUPPL-9	Labeling		Label is not available on this site.
05/31/1979	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
06/03/1980	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
04/17/1980	SUPPL-6	Labeling		Label is not available on this site.
09/06/1977	SUPPL-5	Manufacturing (CMC)-Packaging		Label is not available on this site.
05/31/1974	SUPPL-4			Label is not available on this site.