Application 207419
- Type
- ANDA
- Sponsor
- ASCENT PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 325MG;2.5MG | No | No |
| 002 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 325MG;5MG | No | No |
| 003 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 325MG;7.5MG | No | No |
| 004 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 325MG;10MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A207419-001 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;2.5MG | TABLET / ORAL | AA | 2017-03-22 | |
| A207419-002 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;5MG | TABLET / ORAL | AA | 2017-03-22 | |
| A207419-003 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;7.5MG | TABLET / ORAL | AA | 2017-03-22 | |
| A207419-004 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;10MG | TABLET / ORAL | AA | 2017-03-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A207419-001 | AA |
| A207419-002 | AA |
| A207419-003 | AA |
| A207419-004 | AA |
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 | A207419-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | AA | 2017-03-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207419-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-03-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207419-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2017-03-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207419-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2017-03-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207419-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | AA | 2017-03-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207419-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-03-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207419-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2017-03-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207419-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2017-03-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207419-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | AA | 2017-03-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207419-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-03-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207419-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2017-03-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207419-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2017-03-22 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207419-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | AA | 2017-03-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207419-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-03-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207419-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2017-03-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207419-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2017-03-22 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207419-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | AA | 2017-03-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207419-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-03-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207419-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2017-03-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207419-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2017-03-22 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207419-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | AA | 2017-03-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207419-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-03-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207419-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2017-03-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207419-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2017-03-22 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207419-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | AA | 2017-03-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207419-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-03-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207419-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2017-03-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207419-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2017-03-22 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207419-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | AA | 2017-03-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207419-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-03-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207419-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2017-03-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207419-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2017-03-22 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207419-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | AA | 2017-03-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207419-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-03-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207419-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2017-03-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207419-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2017-03-22 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207419-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | AA | 2017-03-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207419-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-03-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207419-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2017-03-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207419-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2017-03-22 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A207419-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207419-002 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207419-003 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207419-004 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207419-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207419-002 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207419-003 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207419-004 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A207419-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207419-002 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207419-003 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207419-004 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207419-001 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207419-002 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207419-003 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207419-004 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207419-001 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207419-002 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207419-003 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207419-004 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207419-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207419-002 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207419-003 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207419-004 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207419-001 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207419-002 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207419-003 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207419-004 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207419-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207419-002 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207419-003 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207419-004 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207419-001 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207419-002 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207419-003 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207419-004 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A207419-001 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A207419-002 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A207419-003 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A207419-004 | AA | 1 | d06236e962d9… |
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 AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | Camber Pharmaceuticals, Inc. | 42777191-0454-4ccb-8fc3-8b18b0ee43f7 | 2025-08-05 | Boxed warning, Warnings, Adverse reactions | 207419 ANDA207419 31722-948 31722-951 31722-949 31722-950 |
| OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | Direct_Rx | 90a11364-fc42-e94e-e053-2a95a90a9782 | 2025-07-22 | Boxed warning, Warnings, Adverse reactions | 207419 ANDA207419 61919-871 |
| OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | Asclemed USA, Inc. | 71c7a627-6ed9-4f49-8cdc-b3228c021e64 | 2025-04-15 | Boxed warning, Warnings, Adverse reactions | 207419 ANDA207419 |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | Direct_Rx | e4e27022-581e-ba8c-e053-2a95a90a1ae4 | 2025-04-07 | Warnings, Adverse reactions | 207419 ANDA207419 |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | NuCare Pharmaceuticals,Inc. | 9e4024f4-0f60-dfef-e053-2995a90ac366 | 2024-06-20 | Boxed warning, Warnings, Adverse reactions | 207419 ANDA207419 68071-5169 |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | NuCare Pharmaceuticals,Inc. | 925f9787-3d1c-0189-e053-2a95a90a2972 | 2024-06-19 | Boxed warning, Warnings, Adverse reactions | 207419 ANDA207419 68071-5054 |
| OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | Bryant Ranch Prepack | 4a873428-bb5a-4e48-9185-2a27f289110d | 2024-05-31 | Boxed warning, Warnings, Adverse reactions | 207419 ANDA207419 |
| OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | Bryant Ranch Prepack | 88d05136-7b04-4b25-af1c-6bc72fdbcbd7 | 2024-05-31 | Boxed warning, Warnings, Adverse reactions | 207419 ANDA207419 |
| OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | Bryant Ranch Prepack | 96173ce4-4836-43ae-9797-5246f830643a | 2024-05-31 | Boxed warning, Warnings, Adverse reactions | 207419 ANDA207419 |
| OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | Bryant Ranch Prepack | 3791abd3-fcdf-4c8d-b46d-db6e5c805770 | 2024-05-30 | Boxed warning, Warnings, Adverse reactions | 207419 ANDA207419 63629-8888 |
| OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | Bryant Ranch Prepack | 0c85d1b8-ea42-421d-a305-4d338b47150f | 2024-05-30 | Boxed warning, Warnings, Adverse reactions | 207419 ANDA207419 63629-8834 |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | Bryant Ranch Prepack | 4da8a7bd-0d2e-452c-afb5-fed4e230a9bd | 2024-04-08 | Boxed warning, Warnings, Adverse reactions | 207419 ANDA207419 |
| OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | XLCare Pharmaceuticals, Inc. | 7f3c6dd7-6bc8-450e-aded-997f9cf63a8f | 2024-02-12 | Boxed warning, Warnings, Adverse reactions | 207419 ANDA207419 |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | Proficient Rx LP | 78933d4a-d78a-43bc-9052-a032901ee050 | 2022-11-01 | Boxed warning, Warnings, Adverse reactions | 207419 ANDA207419 71205-486 |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | Proficient Rx LP | 5df7c033-0f31-45bc-8c34-3da45635e66d | 2022-11-01 | Boxed warning, Warnings, Adverse reactions | 207419 ANDA207419 71205-347 |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | Proficient Rx LP | 484a4323-0758-439d-844f-f04d7e5ef6f3 | 2022-08-01 | Boxed warning, Warnings, Adverse reactions | 207419 ANDA207419 71205-329 |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | Camber Pharmaceuticals, Inc. | 2a49ee34-6f1d-4ed3-8daa-343723d2a2be | 2018-02-20 | Boxed warning, Warnings, Adverse reactions | 207419 ANDA207419 31722-191 31722-192 31722-194 31722-193 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 31722-191 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-192 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-193 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-194 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-948 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-948 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-948 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-948 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Camber Pharmaceuticals Inc | ANDA | Current |
| 31722-948 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Camber Pharmaceuticals Inc | ANDA | Current |
| 31722-949 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-949 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-949 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-949 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Camber Pharmaceuticals Inc | ANDA | Current |
| 31722-949 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Camber Pharmaceuticals Inc | ANDA | Current |
| 31722-950 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-950 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-950 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-950 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Camber Pharmaceuticals Inc | ANDA | Current |
| 31722-950 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Camber Pharmaceuticals Inc | ANDA | Current |
| 31722-951 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-951 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-951 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-951 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Camber Pharmaceuticals Inc | ANDA | Current |
| 31722-951 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Camber Pharmaceuticals Inc | ANDA | Current |
| 55700-967 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Quality Care Products, LLC | ANDA | Current |
| 55700-967 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Quality Care Products, LLC | ANDA | Current |
| 55700-967 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Quality Care Products, LLC | ANDA | Current |
| 55700-970 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Quality Care Products, LLC | ANDA | Current |
| 61919-835 | Oxycodone/APAP | Oxycodone/APAP | Direct_Rx | ANDA | Current |
| 61919-835 | Oxycodone/APAP | Oxycodone/APAP | Direct_Rx | ANDA | Current |
| 61919-871 | OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | Direct_Rx | ANDA | Current |
| 61919-871 | OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | Direct_Rx | ANDA | Current |
| 61919-871 | OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | Direct_Rx | ANDA | Current |
| 61919-871 | OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | Direct_Rx | ANDA | Current |
| 61919-871 | OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | Direct_Rx | ANDA | Current |
| 61919-871 | OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | Direct_Rx | ANDA | Current |
| 63629-1907 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-1907 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-1907 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-1908 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-1908 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-1908 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-1909 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-1909 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-1909 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-1910 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-1910 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-1910 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-1911 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-1911 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-1911 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-1912 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-1912 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-1912 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-7825 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-8834 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-8888 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 67296-1531 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1531 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1531 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1815 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | RedPharm Drug,Inc. | ANDA | Current |
| 67296-1815 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | RedPharm Drug,Inc. | ANDA | Current |
| 67296-1815 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | RedPharm Drug,Inc. | ANDA | Current |
| 67296-1815 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | RedPharm Drug,Inc. | ANDA | Current |
| 68071-4839 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4839 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4852 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4852 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5054 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5054 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5054 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5054 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5169 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5169 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 71205-329 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Proficient Rx LP | ANDA | Current |
| 71205-329 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Proficient Rx LP | ANDA | Current |
| 71205-329 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Proficient Rx LP | ANDA | Current |
| 71205-347 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Proficient Rx LP | ANDA | Current |
| 71205-347 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Proficient Rx LP | ANDA | Current |
| 71205-486 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Proficient Rx LP | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76532 | ORIG | 2023-11-08 |