Application 020616
- Type
- NDA
- Sponsor
- ALLERGAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | KADIAN | MORPHINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 20MG | Yes | No |
| 002 | KADIAN | MORPHINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 50MG | Yes | No |
| 003 | KADIAN | MORPHINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 100MG | Yes | Yes |
| 004 | KADIAN | MORPHINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 30MG | Yes | No |
| 005 | KADIAN | MORPHINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 60MG | Yes | No |
| 006 | KADIAN | MORPHINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 80MG | Yes | No |
| 007 | KADIAN | MORPHINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 200MG | Yes | Yes |
| 008 | KADIAN | MORPHINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 10MG | Yes | Yes |
| 009 | KADIAN | MORPHINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 40MG | Yes | No |
| 010 | KADIAN | MORPHINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 70MG | Yes | No |
| 011 | KADIAN | MORPHINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 130MG | Yes | No |
| 012 | KADIAN | MORPHINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 150MG | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0023-6011 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6011 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6011 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6011 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6011 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6011 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6012 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6012 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6012 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6012 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6012 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6012 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6013 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6013 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6013 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6013 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6013 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6013 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6014 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6014 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6014 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6014 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6014 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6015 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6015 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6015 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6015 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6015 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6015 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6016 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6016 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6016 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6016 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6016 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6016 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6017 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6017 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6017 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6017 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6017 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6017 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6018 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6018 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6018 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6018 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6018 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6018 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6019 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6019 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6019 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6019 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6019 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6019 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0228-3501 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3501 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3501 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3501 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3501 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3501 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3501 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3502 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3502 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3502 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3502 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3502 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3502 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3502 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3503 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3503 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3503 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3503 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3503 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3503 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3503 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3504 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3504 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3504 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3504 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3504 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3504 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 66587 | SUPPL | 2021-03-08 |
| 66586 | SUPPL | 2021-03-08 |
| 66505 | SUPPL | 2021-03-05 |
| 60343 | SUPPL | 2019-10-08 |
| 60329 | SUPPL | 2019-10-08 |
| 60328 | SUPPL | 2019-10-08 |
| 55901 | SUPPL | 2018-10-12 |
| 55900 | SUPPL | 2018-10-12 |
| 55661 | SUPPL | 2018-09-28 |
| 55660 | SUPPL | 2018-09-28 |
| 48568 | SUPPL | 2017-05-30 |
| 46383 | SUPPL | 2016-12-21 |
| 46253 | SUPPL | 2016-12-20 |
| 45462 | SUPPL | 2016-10-04 |
| 2888 | SUPPL | 2016-04-22 |
| 2887 | SUPPL | 2015-07-02 |
| 2886 | SUPPL | 2014-08-20 |
| 2885 | SUPPL | 2014-04-17 |
| 34964 | SUPPL | 2014-04-16 |
| 25330 | SUPPL | 2013-04-17 |
| 2884 | SUPPL | 2013-03-29 |
| 34963 | SUPPL | 2012-07-13 |
| 34962 | SUPPL | 2012-07-12 |
| 44453 | ORIG | 2012-07-11 |
| 25329 | SUPPL | 2012-07-11 |
| 20768 | SUPPL | 2011-02-04 |
| 41484 | SUPPL | 2007-11-19 |
| 41483 | SUPPL | 2007-11-19 |
| 25328 | SUPPL | 2007-05-01 |
| 12854 | SUPPL | 2007-04-25 |
| 34960 | SUPPL | 2007-03-07 |
| 25327 | SUPPL | 2007-03-07 |
| 12853 | SUPPL | 2007-03-07 |
| 2882 | SUPPL | 2007-03-07 |
| 34961 | SUPPL | 2006-11-06 |
| 2883 | SUPPL | 2006-11-06 |
| 25326 | SUPPL | 2005-10-20 |
| 12852 | SUPPL | 2005-09-30 |