Application 022321
- Type
- NDA
- Sponsor
- ALPHARMA PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EMBEDA | MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 20MG;0.8MG | Yes | No |
| 002 | EMBEDA | MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 30MG;1.2MG | Yes | No |
| 003 | EMBEDA | MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 50MG;2MG | Yes | No |
| 004 | EMBEDA | MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 60MG;2.4MG | Yes | No |
| 005 | EMBEDA | MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 80MG;3.2MG | Yes | No |
| 006 | EMBEDA | MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 100MG;4MG | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 60793-430 | EMBEDA | MORPHINE SULFATE and NALTREXONE HYDROCHLORIDE | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 60793-430 | EMBEDA | MORPHINE SULFATE and NALTREXONE HYDROCHLORIDE | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 60793-431 | EMBEDA | MORPHINE SULFATE and NALTREXONE HYDROCHLORIDE | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 60793-431 | EMBEDA | MORPHINE SULFATE and NALTREXONE HYDROCHLORIDE | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 60793-433 | EMBEDA | MORPHINE SULFATE and NALTREXONE HYDROCHLORIDE | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 60793-433 | EMBEDA | MORPHINE SULFATE and NALTREXONE HYDROCHLORIDE | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 60793-434 | EMBEDA | MORPHINE SULFATE and NALTREXONE HYDROCHLORIDE | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 60793-434 | EMBEDA | MORPHINE SULFATE and NALTREXONE HYDROCHLORIDE | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 60793-435 | EMBEDA | MORPHINE SULFATE and NALTREXONE HYDROCHLORIDE | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 60793-435 | EMBEDA | MORPHINE SULFATE and NALTREXONE HYDROCHLORIDE | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 60793-437 | EMBEDA | MORPHINE SULFATE and NALTREXONE HYDROCHLORIDE | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 60793-437 | EMBEDA | MORPHINE SULFATE and NALTREXONE HYDROCHLORIDE | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 60386 | SUPPL | 2019-10-08 |
| 60385 | SUPPL | 2019-10-08 |
| 60366 | SUPPL | 2019-10-08 |
| 55689 | SUPPL | 2018-10-01 |
| 55688 | SUPPL | 2018-10-01 |
| 55637 | SUPPL | 2018-09-27 |
| 55636 | SUPPL | 2018-09-27 |
| 55635 | SUPPL | 2018-09-27 |
| 55634 | SUPPL | 2018-09-27 |
| 48582 | SUPPL | 2017-05-31 |
| 46339 | SUPPL | 2016-12-21 |
| 46332 | SUPPL | 2016-12-21 |
| 45467 | SUPPL | 2016-10-04 |
| 29594 | SUPPL | 2016-04-22 |
| 44495 | ORIG | 2015-11-04 |
| 29593 | SUPPL | 2015-07-06 |
| 43556 | SUPPL | 2014-10-17 |
| 29592 | SUPPL | 2014-10-17 |
| 17240 | SUPPL | 2014-10-17 |
| 7235 | SUPPL | 2014-08-20 |
| 7234 | SUPPL | 2014-04-17 |
| 17241 | SUPPL | 2014-04-16 |
| 17239 | SUPPL | 2013-11-05 |
| 29591 | SUPPL | 2013-06-04 |
| 17238 | SUPPL | 2013-06-03 |
| 7233 | SUPPL | 2013-04-18 |
| 17237 | SUPPL | 2012-07-12 |
| 44496 | ORIG | 2012-07-11 |
| 29590 | SUPPL | 2012-07-11 |
| 42492 | ORIG | 2010-05-25 |
| 7232 | ORIG | 2009-08-19 |
| 38573 | ORIG | 2009-08-18 |