Application 201655
- Type
- NDA
- Sponsor
- ENDO PHARMS
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OPANA ER | OXYMORPHONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 5MG | Yes | No |
| 002 | OPANA ER | OXYMORPHONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 7.5MG | Yes | No |
| 003 | OPANA ER | OXYMORPHONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 10MG | Yes | No |
| 004 | OPANA ER | OXYMORPHONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 15MG | Yes | No |
| 005 | OPANA ER | OXYMORPHONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 20MG | Yes | No |
| 006 | OPANA ER | OXYMORPHONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 30MG | Yes | No |
| 007 | OPANA ER | OXYMORPHONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 40MG | Yes | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 35356-820 | Opana | oxymorphone hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | NDA | Current |
| 35356-825 | Opana | oxymorphone hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | NDA | Current |
| 35356-848 | Opana | oxymorphone hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | NDA | Current |
| 35356-849 | Opana | oxymorphone hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | NDA | Current |
| 63481-812 | Opana | oxymorphone hydrochloride | Endo Pharmaceuticals, Inc. | NDA | Current |
| 63481-812 | Opana | oxymorphone hydrochloride | Endo Pharmaceuticals Inc. | NDA | Current |
| 63481-813 | Opana | oxymorphone hydrochloride | Endo Pharmaceuticals, Inc. | NDA | Current |
| 63481-814 | Opana | oxymorphone hydrochloride | Endo Pharmaceuticals, Inc. | NDA | Current |
| 63481-814 | Opana | oxymorphone hydrochloride | Endo Pharmaceuticals Inc. | NDA | Current |
| 63481-815 | Opana | oxymorphone hydrochloride | Endo Pharmaceuticals, Inc. | NDA | Current |
| 63481-815 | Opana | oxymorphone hydrochloride | Endo Pharmaceuticals Inc. | NDA | Current |
| 63481-816 | Opana | oxymorphone hydrochloride | Endo Pharmaceuticals, Inc. | NDA | Current |
| 63481-817 | Opana | oxymorphone hydrochloride | Endo Pharmaceuticals, Inc. | NDA | Current |
| 63481-818 | Opana | oxymorphone hydrochloride | Endo Pharmaceuticals, Inc. | NDA | Current |
Documents
| Document | Submission type | Date |
|---|---|---|
| 60452 | SUPPL | 2019-10-09 |
| 60403 | SUPPL | 2019-10-09 |
| 60402 | SUPPL | 2019-10-07 |
| 55716 | SUPPL | 2018-10-01 |
| 55715 | SUPPL | 2018-10-01 |
| 55578 | SUPPL | 2018-09-24 |
| 55577 | SUPPL | 2018-09-24 |
| 48584 | SUPPL | 2017-05-31 |
| 46424 | SUPPL | 2016-12-21 |
| 46307 | SUPPL | 2016-12-20 |
| 45455 | SUPPL | 2016-10-03 |
| 32129 | SUPPL | 2016-04-22 |
| 32128 | SUPPL | 2015-07-07 |
| 40080 | SUPPL | 2015-01-30 |
| 9919 | SUPPL | 2015-01-29 |
| 9918 | SUPPL | 2014-08-20 |
| 9917 | SUPPL | 2014-04-17 |
| 40079 | SUPPL | 2014-04-16 |
| 9916 | SUPPL | 2013-04-18 |
| 32127 | SUPPL | 2013-01-16 |
| 19028 | SUPPL | 2013-01-14 |
| 24398 | ORIG | 2012-08-27 |
| 22854 | ORIG | 2012-08-27 |
| 40078 | SUPPL | 2012-07-12 |
| 9915 | SUPPL | 2012-07-11 |
| 44574 | ORIG | 2012-01-05 |
| 40077 | ORIG | 2011-12-09 |
| 32126 | ORIG | 2011-12-09 |