Drugs@FDA: FDA Approved Drug Products

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

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