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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A077290-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2005-12-08 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A077290-002 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2005-12-08 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A077290-003 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | 2005-12-08 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A077290-004 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | 2005-12-08 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A077290-005 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2005-12-08 | 84e616aacf4f… | ||
| 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… |
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 | Strides Pharma Science Limited | f3116ebf-d72c-4e98-aa50-006be4770c86 | 2026-01-09 | Boxed warning, Warnings, Adverse reactions | Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE |
| OXAYDO | OXYCODONE HYDROCHLORIDE | Zyla Life Sciences US LLC | cff0c64a-63f5-4b3c-909a-cdecf6755cbe | 2026-01-04 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
| Oxycodone hydrochloride | OXYCODONE HYDROCHLORIDE | Alvogen, Inc. | 20bb6bb4-230a-c9c2-01d8-a6e9341e96ba | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | Oxycodone hydrochloride OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Asclemed USA, Inc. | 056bdaac-4a43-42f0-9435-f349d3ccc128 | 2025-12-27 | Boxed warning, Warnings, Adverse reactions | Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Aurolife Pharma, LLC | 96ad4352-fff3-46a7-85de-466cc161045e | 2025-12-23 | Boxed warning, Warnings, Adverse reactions | Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Redpharm Drug | 3745020d-df8c-7209-e063-6394a90aabd7 | 2025-12-11 | Boxed warning, Warnings, Adverse reactions | Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Redpharm Drug | 439c2de6-3ea5-e829-e063-6294a90aa77d | 2025-12-02 | Boxed warning, Warnings, Adverse reactions | Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | PAI Holdings, LLC dba PAI Pharma | 73b063b5-24b7-40bf-bc2a-c0e1bfaf61d1 | 2025-11-28 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | American Health Packaging | aa7ac2bf-d9ed-445d-b394-4d3fe39780ca | 2025-10-17 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | 08977126-9671-4d87-9724-1599ca86e181 | 2025-10-16 | Boxed warning, Warnings, Adverse reactions | Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | ST. MARY'S MEDICAL PARK PHARMACY | 3cd01fb7-b59c-fc5d-e063-6394a90a21d2 | 2025-08-20 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | ST. MARY'S MEDICAL PARK PHARMACY | 3ca9f0d9-a40d-4416-e063-6394a90aec8b | 2025-08-18 | Boxed warning, Warnings, Adverse reactions | Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | DIRECT RX | a8206207-ad09-83df-e053-2995a90a78b7 | 2025-06-05 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | RedPharm Drug, Inc. | 92614a3a-331d-16ad-e053-2a95a90a47cc | 2025-04-09 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | American Health Packaging | 0a6b0659-6816-4f44-81bd-9bac4da5380d | 2025-03-20 | Boxed warning, Warnings, Adverse reactions | Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | e2e52a0e-a80b-4225-b034-37a62f839d92 | 2025-01-23 | Boxed warning, Warnings, Adverse reactions | Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Asclemed USA, Inc. | c10cc127-8756-4ddc-9f46-1e003ef271dc | 2025-01-08 | Boxed warning, Warnings, Adverse reactions | Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Quality Care Products LLC | 4cadb809-157d-49cc-97b4-3276594f19d2 | 2024-12-19 | Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Precision Dose, Inc. | f849c7cc-fa85-47eb-be30-1be137913bf9 | 2024-12-17 | Boxed warning, Warnings, Adverse reactions | Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | d9841f2d-d182-4888-9a3c-68e1afb3e19c | 2024-11-20 | Boxed warning, Warnings, Adverse reactions | Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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 |