Application 207510
- Type
- ANDA
- Sponsor
- WES PHARMA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 325MG;5MG | No | No |
| 002 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 325MG;7.5MG | No | No |
| 003 | 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 |
|---|---|---|---|---|---|---|---|
| A207510-001 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;5MG | TABLET / ORAL | AA | 2018-03-21 | |
| A207510-002 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;7.5MG | TABLET / ORAL | AA | 2018-03-21 | |
| A207510-003 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;10MG | TABLET / ORAL | AA | 2018-03-21 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A207510-001 | AA |
| A207510-002 | AA |
| A207510-003 | 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 | A207510-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2018-03-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207510-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2018-03-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207510-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2018-03-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207510-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2018-03-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207510-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2018-03-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207510-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2018-03-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207510-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2018-03-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207510-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2018-03-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207510-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2018-03-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207510-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2018-03-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207510-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2018-03-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207510-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2018-03-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207510-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2018-03-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207510-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2018-03-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207510-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2018-03-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207510-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2018-03-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207510-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2018-03-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207510-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2018-03-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207510-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2018-03-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207510-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2018-03-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207510-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2018-03-21 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207510-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2018-03-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207510-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2018-03-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207510-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2018-03-21 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207510-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2018-03-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207510-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2018-03-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207510-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2018-03-21 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207510-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2018-03-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207510-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2018-03-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207510-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2018-03-21 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207510-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2018-03-21 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207510-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2018-03-21 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207510-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2018-03-21 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207510-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2018-03-21 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207510-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2018-03-21 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207510-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2018-03-21 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207510-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2018-03-21 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207510-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2018-03-21 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207510-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2018-03-21 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A207510-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2018-03-21 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A207510-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207510-002 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207510-003 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207510-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207510-002 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207510-003 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A207510-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207510-002 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207510-003 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207510-001 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207510-002 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207510-003 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207510-001 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207510-002 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207510-003 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207510-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207510-002 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207510-003 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207510-001 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207510-002 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207510-003 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207510-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207510-002 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207510-003 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207510-001 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207510-002 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207510-003 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A207510-001 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A207510-002 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A207510-003 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207510-001 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207510-002 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207510-003 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207510-001 | AA | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207510-002 | AA | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207510-003 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207510-001 | AA | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207510-002 | AA | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207510-003 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A207510-001 | AA | 1 | 8072bd15b7f6… |
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 | Major Pharmaceuticals | 1d52272f-a607-4002-a61c-341964522b82 | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | 207510 ANDA207510 0904-7094 0904-7093 0904-7095 |
| OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | Bryant Ranch Prepack | 25c03c47-0057-41b6-a530-c6ea85eb750f | 2026-06-29 | Boxed warning, Warnings, Adverse reactions | 207510 ANDA207510 |
| OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | Eywa Pharma Inc | 1da85ac1-46a2-4081-b533-4890ec9e0482 | 2026-05-28 | Boxed warning, Warnings, Adverse reactions | 207510 ANDA207510 71930-047 71930-045 71930-046 |
| OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | Bryant Ranch Prepack | 3339d3bd-b416-4c5b-8984-0c376544d8a9 | 2026-04-13 | Boxed warning, Warnings, Adverse reactions | 207510 ANDA207510 |
| OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | Asclemed USA, Inc. | e0d06ec7-9846-4e04-8660-5fd6b2b8e423 | 2025-11-25 | Boxed warning, Warnings, Adverse reactions | 207510 ANDA207510 |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | American Health Packaging | 79bb61d7-8836-4ce7-91bc-9463efbad9cf | 2025-11-25 | Boxed warning, Warnings, Adverse reactions | 207510 ANDA207510 60687-642 |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | DIRECT RX | a8206207-ad09-83df-e053-2995a90a78b7 | 2025-06-05 | Boxed warning, Warnings, Adverse reactions | 207510 ANDA207510 72189-255 72189-256 |
| OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | Bryant Ranch Prepack | 71b1a9be-3231-4b09-a195-d5893104bd4a | 2024-05-23 | Boxed warning, Warnings, Adverse reactions | 207510 ANDA207510 71335-2049 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0904-7093 | OXYCODONE AND ACETAMINOPHEN | oxycodone and acetaminophen | Major Pharmaceuticals | ANDA | Current |
| 0904-7093 | OXYCODONE AND ACETAMINOPHEN | oxycodone and acetaminophen | Major Pharmaceuticals | ANDA | Current |
| 0904-7094 | OXYCODONE AND ACETAMINOPHEN | oxycodone and acetaminophen | Major Pharmaceuticals | ANDA | Current |
| 0904-7094 | OXYCODONE AND ACETAMINOPHEN | oxycodone and acetaminophen | Major Pharmaceuticals | ANDA | Current |
| 0904-7095 | OXYCODONE AND ACETAMINOPHEN | oxycodone and acetaminophen | Major Pharmaceuticals | ANDA | Current |
| 0904-7095 | OXYCODONE AND ACETAMINOPHEN | oxycodone and acetaminophen | Major Pharmaceuticals | ANDA | Current |
| 43598-546 | oxycodone and acetaminophen | oxycodone and acetaminophen | Dr. Reddy | ANDA | Current |
| 43598-546 | oxycodone and acetaminophen | oxycodone and acetaminophen | Dr. Reddy | ANDA | Current |
| 43598-546 | oxycodone and acetaminophen | oxycodone and acetaminophen | Dr. Reddy | ANDA | Current |
| 43598-547 | oxycodone and acetaminophen | oxycodone and acetaminophen | Dr. Reddy | ANDA | Current |
| 43598-547 | oxycodone and acetaminophen | oxycodone and acetaminophen | Dr. Reddy | ANDA | Current |
| 43598-547 | oxycodone and acetaminophen | oxycodone and acetaminophen | Dr. Reddy | ANDA | Current |
| 60687-642 | OXYCODONE AND ACETAMINOPHEN | oxycodone and acetaminophen | American Health Packaging | ANDA | Current |
| 60687-642 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | American Health Packaging | ANDA | Current |
| 63629-1942 | OXYCODONE AND ACETAMINOPHEN | oxycodone and acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-1942 | OXYCODONE AND ACETAMINOPHEN | oxycodone and acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-1943 | OXYCODONE AND ACETAMINOPHEN | oxycodone and acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-1943 | OXYCODONE AND ACETAMINOPHEN | oxycodone and acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 68071-2598 | OXYCODONE AND ACETAMINOPHEN | oxycodone and acetaminophen | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2856 | OXYCODONE AND ACETAMINOPHEN | oxycodone and acetaminophen | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 71335-2049 | OXYCODONE AND ACETAMINOPHEN | oxycodone and acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 71930-045 | OXYCODONE AND ACETAMINOPHEN | oxycodone and acetaminophen | Eywa Pharma Inc | ANDA | Current |
| 71930-045 | OXYCODONE AND ACETAMINOPHEN | oxycodone and acetaminophen | Eywa Pharma Inc | ANDA | Current |
| 71930-045 | OXYCODONE AND ACETAMINOPHEN | oxycodone and acetaminophen | Eywa Pharma Inc | ANDA | Current |
| 71930-045 | OXYCODONE AND ACETAMINOPHEN | oxycodone and acetaminophen | Eywa Pharma Inc | ANDA | Current |
| 71930-046 | OXYCODONE AND ACETAMINOPHEN | oxycodone and acetaminophen | Eywa Pharma Inc | ANDA | Current |
| 71930-046 | OXYCODONE AND ACETAMINOPHEN | oxycodone and acetaminophen | Eywa Pharma Inc | ANDA | Current |
| 71930-046 | OXYCODONE AND ACETAMINOPHEN | oxycodone and acetaminophen | Eywa Pharma Inc | ANDA | Current |
| 71930-046 | OXYCODONE AND ACETAMINOPHEN | oxycodone and acetaminophen | Eywa Pharma Inc | ANDA | Current |
| 71930-047 | OXYCODONE AND ACETAMINOPHEN | oxycodone and acetaminophen | Eywa Pharma Inc | ANDA | Current |
| 71930-047 | OXYCODONE AND ACETAMINOPHEN | oxycodone and acetaminophen | Eywa Pharma Inc | ANDA | Current |
| 71930-047 | OXYCODONE AND ACETAMINOPHEN | oxycodone and acetaminophen | Eywa Pharma Inc | ANDA | Current |
| 71930-047 | OXYCODONE AND ACETAMINOPHEN | oxycodone and acetaminophen | Eywa Pharma Inc | ANDA | Current |
| 72189-255 | OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | DIRECT RX | ANDA | Current |
| 72189-255 | OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | DIRECT RX | ANDA | Current |
| 72189-256 | OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | DIRECT RX | ANDA | Current |
| 72189-256 | OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | DIRECT RX | ANDA | Current |
| 72189-257 | OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | DirectRx | ANDA | Current |
| 72189-257 | OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | DirectRx | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76201 | ORIG | 2023-11-03 |