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 | AP | Yes | Yes |
| EXPAREL | BUPIVACAINE | 266MG/20ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL;INJECTION | Prescription | AP | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 10/28/2011 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022496s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022496s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022496Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/28/2023 | SUPPL-51 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022496s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022496Orig1s051ltr.pdf | |
| 11/09/2023 | SUPPL-44 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022496s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022496Orig1s044ltr.pdf | |
| 04/02/2021 | SUPPL-37 | Manufacturing (CMC)-Manufacturing Process |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/22496Orig1s037.pdf |
| 01/06/2021 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022496Orig1s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022496Orig1s036ltr.pdf | |
| 03/22/2021 | SUPPL-35 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022496s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022496Orig1s035ltr.pdf | |
| 11/02/2018 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022496s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022496Orig1s030ltr.pdf | |
| 03/08/2017 | SUPPL-23 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 06/10/2016 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/14/2015 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022496s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022496Orig1s019ltr.pdf | |
| 04/15/2016 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/05/2016 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/08/2015 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/11/2015 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/27/2015 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/27/2015 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/15/2014 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/06/2018 | SUPPL-9 | Efficacy-New Indication |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022496s009lbledt.pdf | |
| 08/13/2014 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/05/2014 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/28/2014 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/05/2014 | SUPPL-5 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022496s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022496Orig1s005ltr.pdf | |
| 07/10/2013 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/28/2023 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022496s051lbl.pdf | |
| 11/09/2023 | SUPPL-44 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022496s044lbl.pdf | |
| 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-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022496s005lbl.pdf | |
| 12/05/2014 | SUPPL-5 | Labeling-Container/Carton Labels | 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 |
EXPAREL
INJECTABLE, LIPOSOMAL;INJECTION; 133MG/10ML (13.3MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BUPIVACAINE LIPOSOME | BUPIVACAINE | 133MG/10ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL;INJECTION | Prescription | No | AP | 214348 | HENGRUI PHARMA |
| EXPAREL | BUPIVACAINE | 133MG/10ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL;INJECTION | Prescription | Yes | AP | 022496 | PACIRA PHARMS INC |
INJECTABLE, LIPOSOMAL;INJECTION; 266MG/20ML (13.3MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BUPIVACAINE LIPOSOME | BUPIVACAINE | 266MG/20ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL;INJECTION | Prescription | No | AP | 214348 | HENGRUI PHARMA |
| EXPAREL | BUPIVACAINE | 266MG/20ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL;INJECTION | Prescription | Yes | AP | 022496 | PACIRA PHARMS INC |