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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050580
Company: BRISTOL MYERS SQUIBB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AZACTAM AZTREONAM 500MG/VIAL INJECTABLE;INJECTION Discontinued None No No
AZACTAM AZTREONAM 1GM/VIAL INJECTABLE;INJECTION Prescription AP Yes Yes
AZACTAM AZTREONAM 2GM/VIAL INJECTABLE;INJECTION Prescription AP Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/16/2021 SUPPL-46 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050580Orig1s046lbl.pdf
04/16/2021 SUPPL-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050580Orig1s046lbl.pdf
06/18/2018 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050580s044lbl.pdf
06/17/2013 SUPPL-42 Labeling-Package Insert Label (PDF) Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050580s042lbl.pdf
01/22/2008 SUPPL-40 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050580s040,050632s013lbl.pdf
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