Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050580
Company: BRISTOL MYERS SQUIBB
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 |