Application 077290
- Type
- ANDA
- Sponsor
- NESHER PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
| 002 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
| 003 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 15MG | No | No |
| 004 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 20MG | No | No |
| 005 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 30MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077290-001 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2005-12-08 | ||
| A077290-002 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2005-12-08 | ||
| A077290-003 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | 2005-12-08 | ||
| A077290-004 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | 2005-12-08 | ||
| A077290-005 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2005-12-08 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A077290-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2005-12-08 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077290-002 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2005-12-08 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077290-003 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | 2005-12-08 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077290-004 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | 2005-12-08 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077290-005 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2005-12-08 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077290-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2005-12-08 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077290-002 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2005-12-08 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077290-003 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | 2005-12-08 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077290-004 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | 2005-12-08 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077290-005 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2005-12-08 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077290-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2005-12-08 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077290-002 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2005-12-08 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077290-003 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | 2005-12-08 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077290-004 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | 2005-12-08 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077290-005 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2005-12-08 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077290-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2005-12-08 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077290-002 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2005-12-08 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077290-003 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | 2005-12-08 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077290-004 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | 2005-12-08 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077290-005 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2005-12-08 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077290-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2005-12-08 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077290-002 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2005-12-08 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077290-003 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | 2005-12-08 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077290-004 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | 2005-12-08 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077290-005 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2005-12-08 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077290-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2005-12-08 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077290-002 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2005-12-08 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077290-003 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | 2005-12-08 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077290-004 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | 2005-12-08 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077290-005 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2005-12-08 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077290-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2005-12-08 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077290-002 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2005-12-08 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077290-003 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | 2005-12-08 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077290-004 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | 2005-12-08 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077290-005 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2005-12-08 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077290-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2005-12-08 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077290-002 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2005-12-08 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077290-003 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | 2005-12-08 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077290-004 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | 2005-12-08 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077290-005 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2005-12-08 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A077290-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A077290-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A077290-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A077290-004 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A077290-005 | AB | 1 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | A077290-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A077290-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A077290-003 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A077290-004 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A077290-005 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A077290-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A077290-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A077290-003 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A077290-004 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A077290-005 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A077290-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A077290-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A077290-003 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A077290-004 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A077290-005 | 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 |
|---|---|---|---|---|---|---|
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | SpecGx LLC | 928227bf-89c5-4c64-9823-0e84cc669388 | 2026-08-07 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | 585405bc-8b85-286f-e063-6394a90aa5cd | 2026-08-06 | Boxed warning, Warnings, Adverse reactions | Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | KVK-Tech, Inc. | 744f5d1c-7427-492c-8994-c8e817793e53 | 2026-07-29 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | 57afed61-79db-ca43-e063-6394a90a68eb | 2026-07-24 | Boxed warning, Warnings, Adverse reactions | Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE | Major Pharmaceuticals | 6b6db42b-9821-4aa6-8566-297037d84079 | 2026-07-23 | Boxed warning, Warnings, Adverse reactions | Oxycodone Hydrochloride |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | 3ccf459a-fb11-e137-e063-6394a90a5a80 | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | 685d9709-028e-4422-bf0c-fde577b718a2 | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Eywa Pharma Inc | c801963d-f54d-4ed5-82c4-8b278528d3dc | 2026-06-30 | Boxed warning, Warnings, Adverse reactions | Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | bb33bf7f-aa70-4e8a-91b2-4e0400dc328e | 2026-06-29 | Boxed warning, Warnings, Adverse reactions | Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE |
| OxyContin | OXYCODONE HYDROCHLORIDE | Knoa Pharma LLC | bfdfe235-d717-4855-a3c8-a13d26dadede | 2026-06-24 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE | Amneal Pharmaceuticals LLC | 094b64b3-cd32-4de5-afb6-ea00d9caad74 | 2026-06-23 | Boxed warning, Warnings, Adverse reactions | Oxycodone Hydrochloride |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | 0e4dd113-87ab-4a5d-846a-446db3cfd469 | 2026-06-16 | Boxed warning, Warnings, Adverse reactions | Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | e84ea009-3cab-4721-bd21-1123eccce515 | 2026-06-16 | Boxed warning, Warnings, Adverse reactions | Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | KVK-TECH,INC | e73897d6-b920-4300-a564-5dbc9c8e9fe9 | 2026-06-04 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Redpharm Drug | 5301d432-7fca-2d72-e063-6394a90a18a4 | 2026-05-30 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | 27124cdf-a3e8-474c-9c1e-6fa48f6ddc05 | 2026-05-29 | Boxed warning, Warnings, Adverse reactions | Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE | Redpharm Drug | 525001a6-68d8-7ef7-e063-6294a90abc5f | 2026-05-21 | Boxed warning, Warnings, Adverse reactions | Oxycodone Hydrochloride |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | ST. MARY'S MEDICAL PARK PHARMACY | 424fdfc7-1c92-2e62-e063-6394a90a136b | 2026-05-19 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Amneal Pharmaceuticals of New York LLC | c2c57ae7-86b9-47bb-a31b-ed1c4327ce7f | 2026-05-15 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Rhodes Pharmaceuticals LLC | a5162476-1217-41c0-bc7e-0a0f123f069f | 2026-05-06 | Boxed warning, Warnings, Adverse reactions | Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0904-6444 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6445 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 50436-0156 | Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Unit Dose Services | ANDA | Current |
| 50436-0158 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Unit Dose Services | ANDA | Current |
| 50436-3182 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Unit Dose Services | ANDA | Current |
| 63629-3775 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 63629-4606 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 63629-4606 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 63629-4606 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 63629-7399 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 63629-7399 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 63629-7399 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 63739-177 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | McKesson Corporation | ANDA | Current |
| 63739-365 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | McKesson Corporation | ANDA | Current |
| 68084-048 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-828 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | American Health Packaging | ANDA | Current |
| 68382-793 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-793 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-793 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-793 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-794 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-794 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-794 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-794 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-795 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-795 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-795 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-795 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-796 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-796 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-796 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-796 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-797 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-797 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-797 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-797 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 71335-0115 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 71335-0115 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 71335-0115 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 71335-0174 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 71335-0174 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 71335-0209 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 71335-0209 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |