Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012034
Company: SCHERING

Products on NDA 012034

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PERMITIL	FLUPHENAZINE HYDROCHLORIDE	0.25MG	TABLET;ORAL	Discontinued	None	No	No
PERMITIL	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET;ORAL	Discontinued	None	No	No
PERMITIL	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET;ORAL	Discontinued	None	No	No
PERMITIL	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 012034

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/09/1959	ORIG-1	Approval	Type 1 - New Molecular Entity	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
10/18/1999	SUPPL-18	Manufacturing (CMC)-Control		Label is not available on this site.
05/19/2000	SUPPL-15	Labeling		Label is not available on this site.
11/12/2002	SUPPL-11	Labeling		Label is not available on this site.
11/12/2002	SUPPL-10	Labeling		Label is not available on this site.
11/12/2002	SUPPL-9	Labeling		Label is not available on this site.
11/12/2002	SUPPL-7	Labeling		Label is not available on this site.
11/12/2002	SUPPL-4	Labeling		Label is not available on this site.