Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022496
Company: PACIRA PHARMS INC
Company: PACIRA PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EXPAREL | BUPIVACAINE | 133MG/10ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL;INJECTION | Prescription | None | Yes | Yes |
| EXPAREL | BUPIVACAINE | 266MG/20ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL;INJECTION | Prescription | None | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/22/2021 | SUPPL-35 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022496s035lbl.pdf | |
| 01/06/2021 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022496Orig1s036lbl.pdf | |
| 11/02/2018 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022496s030lbl.pdf | |
| 04/06/2018 | SUPPL-9 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022496s009lbledt.pdf | |
| 12/14/2015 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022496s019lbl.pdf | |
| 12/05/2014 | SUPPL-5 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022496s005lbl.pdf | |
| 12/05/2014 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022496s005lbl.pdf | |
| 10/28/2011 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022496s000lbl.pdf |