`
`Drugs@FDA: FDA Approved Drug Products
`
`Drugs@FDA: FDA Approved Drug
`Products
`
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`New Drug Application (NDA): 050577
`Company: TEVA PHARMS USA
`
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`
`Products on NDA 050577
`
`CSVExcelPrint
`Drug
`Active
`Name
`Ingredients
`
`STREPTOZOCIN
`ZANOSAR
`Showing 1 to 1 of 1 entries
`
`Strength
`
`Dosage Form/Route
`
`Marketing
`Status
`
`TE
`Code
`
`RLD
`
`1GM/VIAL
`
`INJECTABLE;INJECTION
`
`Prescription
`
`Yes
`
`None
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 050577
`
`Original Approvals or Tentative Approvals
`CSVExcelPrint
`
`
`
`
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`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process
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`Drugs@FDA: FDA Approved Drug Products
`
`Action
`Date
`
`Submission
`
`Action
`Type
`
`Submission
`Classification
`
`Review
`Priority;
`Orphan
`Status
`
`Letters, Reviews,
`Labels, Patient
`Package Insert
`
`05/07/1982 ORIG1
`
`Approval
`
`Type 1 New
`Molecular Entity
`
`STANDARD
`
`Notes
`
`Label is not
`available on
`this site.
`
`Showing 1 to 1 of 1 entries
`
`Supplements
`CSVExcelPrint
`Action
`Date
`
`Submission
`
`Submission
`Classification
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`11/14/2016
`
`SUPPL42
`
`MANUF (CMC)
`
`01/05/2015 SUPPL41
`
`Manufacturing
`(CMC)
`
`01/05/2015 SUPPL40
`
`Manufacturing
`(CMC)
`
`09/23/2014 SUPPL39
`
`Manufacturing
`(CMC)
`
`07/31/2014 SUPPL38
`
`Manufacturing
`(CMC)
`
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`Drugs@FDA: FDA Approved Drug Products
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Action
`Date
`
`Submission
`
`08/09/2013 SUPPL36
`
`Submission
`Classification
`
`Manufacturing
`(CMC)
`
`12/12/2012 SUPPL37
`
`Manufacturing
`(CMC)
`
`12/04/2012 SUPPL35
`
`Manufacturing
`(CMC)
`
`12/04/2012 SUPPL34
`
`Manufacturing
`(CMC)
`
`12/04/2012 SUPPL20
`
`Manufacturing
`(CMC)
`
`01/22/2003 SUPPL16
`
`Labeling
`
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50577slr016ltr.pdf)
`
`12/30/2002 SUPPL14
`
`Labeling
`
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50577slr014ltr.pdf)
`
`10/22/2002 SUPPL17
`
`Manufacturing
`(CMC)Control
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process
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`Drugs@FDA: FDA Approved Drug Products
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Action
`Date
`
`Submission
`
`04/03/2000 SUPPL15
`
`Submission
`Classification
`
`Manufacturing
`(CMC)Control
`
`05/05/1999 SUPPL13
`
`Labeling
`
`06/29/1995 SUPPL12
`
`Manufacturing
`(CMC)Control
`
`09/27/1994 SUPPL11
`
`Manufacturing
`(CMC)
`
`08/11/1994
`
`SUPPL7
`
`Manufacturing
`(CMC)Control
`
`06/14/1993 SUPPL10
`
`Manufacturing
`(CMC)Control
`
`04/22/1988 SUPPL6
`
`Labeling
`
`11/17/1986
`
`SUPPL5
`
`Labeling
`
`Showing 1 to 21 of 21 entries
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