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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089565
Company: HOSPIRA

Products on ANDA 089565

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VINBLASTINE SULFATE	VINBLASTINE SULFATE	10MG/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 089565

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/18/1987	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
09/25/2001	SUPPL-22	Labeling		Label is not available on this site.
07/30/2001	SUPPL-21	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
05/14/2001	SUPPL-20	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
08/08/2000	SUPPL-18	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
05/18/2000	SUPPL-17	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
05/12/2000	SUPPL-16	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
09/11/1997	SUPPL-13	Labeling		Label is not available on this site.
04/28/1995	SUPPL-12	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
01/11/1995	SUPPL-11	Labeling		Label is not available on this site.
04/14/1993	SUPPL-10	Labeling		Label is not available on this site.
04/14/1993	SUPPL-9	Labeling		Label is not available on this site.
09/30/1992	SUPPL-8	Labeling		Label is not available on this site.
07/22/1992	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
12/23/1992	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
12/23/1992	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
01/12/1990	SUPPL-4	Labeling		Label is not available on this site.
09/30/1992	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
09/22/1989	SUPPL-2	Labeling		Label is not available on this site.
05/23/1988	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

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