Application 079087
- Type
- ANDA
- Sponsor
- IMPAX LABS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 5MG | No | No |
| 002 | OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 7.5MG | No | No |
| 003 | OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 10MG | No | No |
| 004 | OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 15MG | No | No |
| 005 | OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 20MG | No | No |
| 006 | OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 30MG | No | No |
| 007 | OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 40MG | No | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A079087-001 | OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | 2010-06-14 | ||
| A079087-002 | OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 7.5MG | TABLET, EXTENDED RELEASE / ORAL | 2010-12-21 | ||
| A079087-003 | OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2010-06-14 | ||
| A079087-004 | OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | 2010-12-21 | ||
| A079087-005 | OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 20MG | TABLET, EXTENDED RELEASE / ORAL | 2010-06-14 | ||
| A079087-006 | OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 2010-07-22 | ||
| A079087-007 | OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 40MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2010-06-14 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A079087-001 | OXYMORPHONE HYDROCHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | 2010-06-14 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079087-002 | OXYMORPHONE HYDROCHLORIDE | 7.5MG | TABLET, EXTENDED RELEASE / ORAL | 2010-12-21 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079087-003 | OXYMORPHONE HYDROCHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2010-06-14 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079087-004 | OXYMORPHONE HYDROCHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | 2010-12-21 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079087-005 | OXYMORPHONE HYDROCHLORIDE | 20MG | TABLET, EXTENDED RELEASE / ORAL | 2010-06-14 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079087-006 | OXYMORPHONE HYDROCHLORIDE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 2010-07-22 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079087-007 | OXYMORPHONE HYDROCHLORIDE | 40MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2010-06-14 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079087-001 | OXYMORPHONE HYDROCHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | 2010-06-14 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079087-002 | OXYMORPHONE HYDROCHLORIDE | 7.5MG | TABLET, EXTENDED RELEASE / ORAL | 2010-12-21 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079087-003 | OXYMORPHONE HYDROCHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2010-06-14 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079087-004 | OXYMORPHONE HYDROCHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | 2010-12-21 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079087-005 | OXYMORPHONE HYDROCHLORIDE | 20MG | TABLET, EXTENDED RELEASE / ORAL | 2010-06-14 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079087-006 | OXYMORPHONE HYDROCHLORIDE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 2010-07-22 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079087-007 | OXYMORPHONE HYDROCHLORIDE | 40MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2010-06-14 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A079087-001 | OXYMORPHONE HYDROCHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | 2010-06-14 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079087-002 | OXYMORPHONE HYDROCHLORIDE | 7.5MG | TABLET, EXTENDED RELEASE / ORAL | 2010-12-21 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079087-003 | OXYMORPHONE HYDROCHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2010-06-14 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079087-004 | OXYMORPHONE HYDROCHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | 2010-12-21 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079087-005 | OXYMORPHONE HYDROCHLORIDE | 20MG | TABLET, EXTENDED RELEASE / ORAL | 2010-06-14 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079087-006 | OXYMORPHONE HYDROCHLORIDE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 2010-07-22 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079087-007 | OXYMORPHONE HYDROCHLORIDE | 40MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2010-06-14 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079087-001 | OXYMORPHONE HYDROCHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | 2010-06-14 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079087-002 | OXYMORPHONE HYDROCHLORIDE | 7.5MG | TABLET, EXTENDED RELEASE / ORAL | 2010-12-21 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079087-003 | OXYMORPHONE HYDROCHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2010-06-14 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079087-004 | OXYMORPHONE HYDROCHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | 2010-12-21 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079087-005 | OXYMORPHONE HYDROCHLORIDE | 20MG | TABLET, EXTENDED RELEASE / ORAL | 2010-06-14 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079087-006 | OXYMORPHONE HYDROCHLORIDE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 2010-07-22 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079087-007 | OXYMORPHONE HYDROCHLORIDE | 40MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2010-06-14 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079087-001 | OXYMORPHONE HYDROCHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | 2010-06-14 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079087-002 | OXYMORPHONE HYDROCHLORIDE | 7.5MG | TABLET, EXTENDED RELEASE / ORAL | 2010-12-21 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079087-003 | OXYMORPHONE HYDROCHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2010-06-14 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079087-004 | OXYMORPHONE HYDROCHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | 2010-12-21 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079087-005 | OXYMORPHONE HYDROCHLORIDE | 20MG | TABLET, EXTENDED RELEASE / ORAL | 2010-06-14 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079087-006 | OXYMORPHONE HYDROCHLORIDE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 2010-07-22 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079087-007 | OXYMORPHONE HYDROCHLORIDE | 40MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2010-06-14 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079087-001 | OXYMORPHONE HYDROCHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | 2010-06-14 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079087-002 | OXYMORPHONE HYDROCHLORIDE | 7.5MG | TABLET, EXTENDED RELEASE / ORAL | 2010-12-21 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079087-003 | OXYMORPHONE HYDROCHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2010-06-14 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079087-004 | OXYMORPHONE HYDROCHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | 2010-12-21 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079087-005 | OXYMORPHONE HYDROCHLORIDE | 20MG | TABLET, EXTENDED RELEASE / ORAL | 2010-06-14 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A079087-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A079087-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A079087-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A079087-004 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A079087-005 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A079087-006 | AB | 1 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | A079087-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A079087-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A079087-003 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A079087-004 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A079087-005 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A079087-006 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A079087-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A079087-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A079087-003 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A079087-004 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A079087-005 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A079087-006 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A079087-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A079087-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A079087-003 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A079087-004 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A079087-005 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A079087-006 | AB | 1 | ea99ee380514… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Oxymorphone hydrochloride | OXYMORPHONE HYDROCHLORIDE | Amneal Pharmaceuticals LLC | 3f4e703a-e398-42fd-8759-e398c79955f1 | 2026-01-15 | Boxed warning, Warnings, Adverse reactions | 079087 ANDA079087 64896-695 64896-696 64896-697 |
| Oxymorphone hydrochloride | OXYMORPHONE HYDROCHLORIDE | Amneal Pharmaceuticals of New York LLC | 557e9610-62d7-42bf-90c1-44215bd8c1f8 | 2024-01-10 | Boxed warning, Warnings, Adverse reactions | 079087 ANDA079087 0115-1316 0115-1315 0115-1231 0115-1233 0115-1234 0115-1317 0115-1232 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0115-1231 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1231 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Impax Generics | ANDA | Current |
| 0115-1231 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1231 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1231 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1231 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1232 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1232 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Impax Generics | ANDA | Current |
| 0115-1232 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1232 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1232 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1232 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1233 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1233 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Impax Generics | ANDA | Current |
| 0115-1233 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1233 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1233 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1233 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1234 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1234 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Impax Generics | ANDA | Current |
| 0115-1234 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1234 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1234 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1234 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1315 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1315 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Impax Generics | ANDA | Current |
| 0115-1315 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1315 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1315 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1315 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1316 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1316 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Impax Generics | ANDA | Current |
| 0115-1316 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1316 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1316 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1316 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1317 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1317 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Impax Generics | ANDA | Current |
| 0115-1317 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1317 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1317 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1317 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 55700-215 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Lake Erie Medical DBA Qua | ANDA | Current |
| 55700-215 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-387 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-387 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-387 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-387 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-387 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-387 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-417 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-417 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-417 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-417 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-423 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-423 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-423 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-423 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-423 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-423 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-788 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 55700-788 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 55700-788 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 55700-788 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 55700-788 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 55700-806 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 64896-695 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Amneal Pharmaceuticals LLC | ANDA | Current |
| 64896-695 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Amneal Pharmaceuticals LLC | ANDA | Current |
| 64896-695 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Amneal Pharmaceuticals LLC | ANDA | Current |
| 64896-695 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Amneal Pharmaceuticals LLC | ANDA | Current |
| 64896-695 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Amneal Pharmaceuticals LLC | ANDA | Current |
| 64896-696 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Amneal Pharmaceuticals LLC | ANDA | Current |
| 64896-696 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Amneal Pharmaceuticals LLC | ANDA | Current |
| 64896-696 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Amneal Pharmaceuticals LLC | ANDA | Current |
| 64896-696 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Amneal Pharmaceuticals LLC | ANDA | Current |
| 64896-696 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Amneal Pharmaceuticals LLC | ANDA | Current |
| 64896-697 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Amneal Pharmaceuticals LLC | ANDA | Current |
| 64896-697 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Amneal Pharmaceuticals LLC | ANDA | Current |
| 64896-697 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Amneal Pharmaceuticals LLC | ANDA | Current |
| 64896-697 | Oxymorphone hydrochloride | Oxymorphone hydrochloride | Amneal Pharmaceuticals LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 44542 | ORIG | 2015-06-30 |