Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050577
Company: TEVA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZANOSAR STREPTOZOCIN 1GM/VIAL INJECTABLE;INJECTION Prescription None Yes 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
05/07/1982 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/14/2016 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

01/05/2015 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

01/05/2015 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

09/23/2014 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

07/31/2014 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

12/12/2012 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

08/09/2013 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

12/04/2012 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

12/04/2012 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

12/04/2012 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

10/22/2002 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

01/22/2003 SUPPL-16 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50577slr016ltr.pdf
04/03/2000 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

12/30/2002 SUPPL-14 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50577slr014ltr.pdf
05/05/1999 SUPPL-13 Labeling

Label is not available on this site.

06/29/1995 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

09/27/1994 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

06/14/1993 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

08/11/1994 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

04/22/1988 SUPPL-6 Labeling

Label is not available on this site.

11/17/1986 SUPPL-5 Labeling

Label is not available on this site.

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