Application 021260
- Type
- NDA
- Sponsor
- KING PHARMS LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AVINZA | MORPHINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 30MG | No | No |
| 002 | AVINZA | MORPHINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 60MG | No | No |
| 003 | AVINZA | MORPHINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 90MG | No | No |
| 004 | AVINZA | MORPHINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 120MG | No | No |
| 005 | AVINZA | MORPHINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 45MG | No | No |
| 006 | AVINZA | MORPHINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 75MG | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 4821 | SUPPL | 2015-07-06 |
| 27252 | SUPPL | 2014-08-20 |
| 4820 | SUPPL | 2014-04-17 |
| 36499 | SUPPL | 2014-04-16 |
| 27251 | SUPPL | 2013-05-08 |
| 36498 | SUPPL | 2013-05-06 |
| 4819 | SUPPL | 2013-04-16 |
| 36497 | SUPPL | 2012-07-12 |
| 14777 | SUPPL | 2012-07-12 |
| 43731 | ORIG | 2012-07-11 |
| 27250 | SUPPL | 2012-07-11 |
| 27249 | SUPPL | 2012-07-11 |
| 23989 | ORIG | 2012-07-11 |
| 4818 | SUPPL | 2008-12-23 |
| 4817 | SUPPL | 2005-10-25 |
| 36496 | SUPPL | 2005-10-24 |
| 42059 | ORIG | 2004-01-15 |
| 14776 | ORIG | 2002-03-20 |
| 4816 | ORIG | 2002-03-20 |