Application 021671
- Type
- NDA
- Sponsor
- PACIRA PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DEPODUR | MORPHINE SULFATE | INJECTABLE, LIPOSOMAL;EPIDURAL | 10MG/ML (10MG/ML) | No | No |
| 002 | DEPODUR | MORPHINE SULFATE | INJECTABLE, LIPOSOMAL;EPIDURAL | 15MG/1.5ML (10MG/ML) | No | No |
| 003 | DEPODUR | MORPHINE SULFATE | INJECTABLE, LIPOSOMAL;EPIDURAL | 20MG/2ML (10MG/ML) | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 5957 | SUPPL | 2009-11-10 |
| 37433 | SUPPL | 2009-10-01 |
| 5956 | SUPPL | 2008-01-09 |
| 37432 | SUPPL | 2007-12-27 |
| 15954 | SUPPL | 2007-02-23 |
| 5955 | SUPPL | 2007-02-23 |
| 28344 | SUPPL | 2007-01-25 |
| 15953 | SUPPL | 2007-01-18 |
| 5954 | SUPPL | 2006-05-25 |
| 37431 | SUPPL | 2006-05-24 |
| 42264 | ORIG | 2006-01-31 |
| 28343 | SUPPL | 2004-08-12 |
| 37430 | ORIG | 2004-05-27 |
| 28342 | ORIG | 2004-05-26 |