Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089703
Company: HOSPIRA

Products on ANDA 089703

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROCHLORPERAZINE EDISYLATE	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 089703

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/07/1988	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
02/14/2001	SUPPL-15	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
05/24/2000	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
12/10/1999	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
08/17/1998	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
08/17/1998	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
12/22/1995	SUPPL-10	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
06/22/1993	SUPPL-9	Labeling		Label is not available on this site.
07/29/1993	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
07/29/1993	SUPPL-7	Labeling		Label is not available on this site.
02/01/1991	SUPPL-5	Labeling		Label is not available on this site.
11/30/1990	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
07/06/1989	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
06/19/1989	SUPPL-2	Labeling		Label is not available on this site.
06/06/1988	SUPPL-1	Labeling		Label is not available on this site.