Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016008
Company: SCHERING

Products on NDA 016008

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PERMITIL	FLUPHENAZINE HYDROCHLORIDE	5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CONCENTRATE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 016008

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/07/1965	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
07/26/1999	SUPPL-17	Manufacturing (CMC)-Control		Label is not available on this site.
04/13/1989	SUPPL-16	Manufacturing (CMC)-Control		Label is not available on this site.
04/13/1989	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
10/04/1988	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
05/19/2000	SUPPL-13	Labeling		Label is not available on this site.
09/11/1986	SUPPL-12	Manufacturing (CMC)-Packaging		Label is not available on this site.
07/28/1989	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
02/26/1987	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
04/19/1982	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.