Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089515
Company: FRESENIUS KABI USA

Products on ANDA 089515

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VINBLASTINE SULFATE	VINBLASTINE SULFATE	1MG/ML	INJECTABLE;INJECTION	Prescription	None	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 089515

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/29/1987	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
10/25/2021	SUPPL-38	Labeling-Package Insert		Label is not available on this site.
11/20/2003	SUPPL-26	Labeling		Label is not available on this site.
12/05/2002	SUPPL-25	Manufacturing (CMC)-Facility		Label is not available on this site.
11/05/2001	SUPPL-24	Labeling		Label is not available on this site.
07/02/1997	SUPPL-21	Labeling		Label is not available on this site.
10/18/1996	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
10/21/1994	SUPPL-19	Labeling		Label is not available on this site.
01/13/1993	SUPPL-18	Labeling		Label is not available on this site.
12/17/1992	SUPPL-17	Labeling		Label is not available on this site.
02/28/1992	SUPPL-16	Labeling		Label is not available on this site.
01/29/1991	SUPPL-12	Labeling		Label is not available on this site.
09/30/1987	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
09/30/1987	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
09/30/1987	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
08/12/1987	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
08/12/1987	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.