Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075493
Company: TEVA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VINCRISTINE SULFATE PFS VINCRISTINE SULFATE 1MG/ML INJECTABLE;INJECTION Prescription AP No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/01/1999 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75493ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/75-493_Vincristine%20Sulfate.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/31/2015 SUPPL-38 Labeling-Package Insert

Label is not available on this site.

05/13/2013 SUPPL-30 Labeling-Package Insert

Label is not available on this site.

08/31/2015 SUPPL-29 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

08/31/2015 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

01/23/2012 SUPPL-22 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

09/17/2002 SUPPL-1 Labeling

Label is not available on this site.

VINCRISTINE SULFATE PFS

INJECTABLE;INJECTION; 1MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
VINCRISTINE SULFATE PFS VINCRISTINE SULFATE 1MG/ML INJECTABLE;INJECTION Prescription No AP 071484 HOSPIRA
VINCRISTINE SULFATE PFS VINCRISTINE SULFATE 1MG/ML INJECTABLE;INJECTION Prescription No AP 075493 TEVA PHARMS USA

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