Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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-Package Insert, Labeling-Container/Carton Labels

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-Package Insert, Labeling-Container/Carton Labels

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English