Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071484
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VINCRISTINE SULFATE PFS VINCRISTINE 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
04/19/1988 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
09/23/2019 SUPPL-44 Labeling-Package Insert

Label is not available on this site.

08/05/2014 SUPPL-42 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/071484s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/071484Orig1s042ltr.pdf
05/07/2013 SUPPL-41 Labeling-Package Insert

Label is not available on this site.

04/24/2015 SUPPL-39 Labeling-Package Insert

Label is not available on this site.

01/23/2012 SUPPL-38 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

01/25/2007 SUPPL-31 Labeling

Label is not available on this site.

09/25/2001 SUPPL-25 Labeling

Label is not available on this site.

05/14/2001 SUPPL-24 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

08/08/2000 SUPPL-22 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

05/18/2000 SUPPL-21 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

05/12/2000 SUPPL-20 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

04/07/1997 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

07/02/1996 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

11/07/1995 SUPPL-14 Labeling

Label is not available on this site.

04/28/1995 SUPPL-13 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

04/16/1997 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

07/01/1994 SUPPL-11 Labeling

Label is not available on this site.

11/03/1992 SUPPL-10 Labeling

Label is not available on this site.

07/16/1991 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/04/1990 SUPPL-5 Labeling

Label is not available on this site.

04/06/1992 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/06/1992 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/14/1989 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/20/1988 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/05/2014 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/071484s042lbl.pdf

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