Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065286
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AZTREONAM AZTREONAM 1GM/VIAL INJECTABLE;INJECTION Discontinued None No No
AZTREONAM AZTREONAM 2GM/VIAL INJECTABLE;INJECTION Discontinued None 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
03/23/2011 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/065286Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/21/2011 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

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