Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089556
Company: FRESENIUS KABI USA

Products on ANDA 089556

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	2.5MG/ML	INJECTABLE;INJECTION	Prescription	None	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 089556

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/16/1987	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/23/2017	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
12/03/2010	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
07/21/2009	SUPPL-14	Labeling		Label is not available on this site.
11/18/2008	SUPPL-12	Labeling		Label is not available on this site.
12/05/2002	SUPPL-8	Manufacturing (CMC)-Facility		Label is not available on this site.
10/15/2001	SUPPL-7	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
09/01/1998	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
01/20/1995	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.