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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 064210
Company: XGEN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
STREPTOMYCIN SULFATE STREPTOMYCIN SULFATE EQ 1GM BASE/VIAL 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
06/30/1998 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/64210ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/10/2015 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

04/30/2012 SUPPL-9 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/064210s009lbl.pdf
07/23/2001 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

07/23/2001 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/11/2000 SUPPL-1 Manufacturing (CMC)-Facility

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/30/2012 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/064210s009lbl.pdf
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