Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089744
Company: HOSPIRA

Products on ANDA 089744

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PHENYTOIN SODIUM	PHENYTOIN SODIUM	50MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 089744

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/18/1987	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
01/29/2014	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
02/14/2001	SUPPL-8	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
03/25/1998	SUPPL-7	Labeling		Label is not available on this site.
12/22/1995	SUPPL-6	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
10/08/1993	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
10/28/1991	SUPPL-3	Labeling		Label is not available on this site.
03/01/1990	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
07/06/1989	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.