Application 201447
- Type
- ANDA
- Sponsor
- ACTAVIS ELIZABETH
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 |
|---|---|---|---|---|---|---|---|
| A201447-001 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;2.5MG | TABLET / ORAL | AA | 2013-04-12 | |
| A201447-002 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;5MG | TABLET / ORAL | AA | 2013-04-12 | |
| A201447-003 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;7.5MG | TABLET / ORAL | AA | 2013-04-12 | |
| A201447-004 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;10MG | TABLET / ORAL | AA | 2013-04-12 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A201447-001 | AA |
| A201447-002 | AA |
| A201447-003 | AA |
| A201447-004 | 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 | A201447-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | AA | 2013-04-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A201447-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2013-04-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A201447-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2013-04-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A201447-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2013-04-12 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201447-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | AA | 2013-04-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201447-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2013-04-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201447-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2013-04-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201447-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2013-04-12 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201447-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | AA | 2013-04-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201447-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2013-04-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201447-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2013-04-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201447-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2013-04-12 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201447-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | AA | 2013-04-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201447-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2013-04-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201447-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2013-04-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201447-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2013-04-12 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201447-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | AA | 2013-04-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201447-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2013-04-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201447-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2013-04-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201447-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2013-04-12 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201447-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | AA | 2013-04-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201447-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2013-04-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201447-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2013-04-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201447-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2013-04-12 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201447-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | AA | 2013-04-12 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201447-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2013-04-12 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201447-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2013-04-12 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201447-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2013-04-12 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201447-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | AA | 2013-04-12 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201447-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2013-04-12 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201447-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2013-04-12 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201447-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2013-04-12 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201447-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | AA | 2013-04-12 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201447-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2013-04-12 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201447-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2013-04-12 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201447-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2013-04-12 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A201447-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | AA | 2013-04-12 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A201447-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2013-04-12 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A201447-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2013-04-12 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A201447-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2013-04-12 | 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 | A201447-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A201447-002 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A201447-003 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A201447-004 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201447-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201447-002 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201447-003 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201447-004 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A201447-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A201447-002 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A201447-003 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A201447-004 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201447-001 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201447-002 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201447-003 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201447-004 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201447-001 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201447-002 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201447-003 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201447-004 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201447-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201447-002 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201447-003 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201447-004 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201447-001 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201447-002 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201447-003 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201447-004 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201447-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201447-002 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201447-003 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201447-004 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201447-001 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201447-002 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201447-003 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201447-004 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A201447-001 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A201447-002 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A201447-003 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A201447-004 | 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 | FH2 Pharma LLC | 88d97caf-bcf5-3cde-e053-2995a90acf4a | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | oxycodone and acetaminophen |
| OXYCODONE AND ACETAMINOPHEN | OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN | SpecGx LLC | f2137f1a-b49a-40bd-97ac-cd6b36e295f4 | 2026-07-27 | Boxed warning, Warnings, Adverse reactions | OXYCODONE AND ACETAMINOPHEN |
| OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | Major Pharmaceuticals | 1d52272f-a607-4002-a61c-341964522b82 | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | OXYCODONE AND ACETAMINOPHEN |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | Bryant Ranch Prepack | ac6b4a26-7ead-458e-8a3d-591aa0709343 | 2026-06-30 | Boxed warning, Warnings, Adverse reactions | Oxycodone and Acetaminophen |
| OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | Bryant Ranch Prepack | 25c03c47-0057-41b6-a530-c6ea85eb750f | 2026-06-29 | Boxed warning, Warnings, Adverse reactions | OXYCODONE AND ACETAMINOPHEN |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | Bryant Ranch Prepack | ef2c1fe2-75dd-43cf-871d-540c5e36d363 | 2026-06-24 | Boxed warning, Warnings, Adverse reactions | Oxycodone and Acetaminophen |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | Bryant Ranch Prepack | fcb09a57-76d8-413c-801b-8d8ea0c3f1db | 2026-06-24 | Boxed warning, Warnings, Adverse reactions | Oxycodone and Acetaminophen |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | Bryant Ranch Prepack | 1c793d37-cbc9-4d76-a84a-d076b5101143 | 2026-06-19 | Boxed warning, Warnings, Adverse reactions | Oxycodone and Acetaminophen |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | St. Mary's Medical Park Pharmacy | 3cd1cb17-4aea-a750-e063-6394a90a9594 | 2026-06-15 | Boxed warning, Warnings, Adverse reactions | Oxycodone and Acetaminophen |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | St. Mary's Medical Park Pharmacy | 3cd2e535-dd11-4bfb-e063-6394a90a9fbc | 2026-06-15 | Boxed warning, Warnings, Adverse reactions | Oxycodone and Acetaminophen |
| OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | Eywa Pharma Inc | 1da85ac1-46a2-4081-b533-4890ec9e0482 | 2026-05-28 | Boxed warning, Warnings, Adverse reactions | OXYCODONE AND ACETAMINOPHEN |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | St. Mary's Medical Park Pharmacy | 3cf4c474-556e-5ebf-e063-6394a90acaf0 | 2026-05-15 | Boxed warning, Warnings, Adverse reactions | Oxycodone and Acetaminophen |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | Bryant Ranch Prepack | 4d9e7c39-3e71-48c7-87c7-302db1835f11 | 2026-05-15 | Boxed warning, Warnings, Adverse reactions | Oxycodone and Acetaminophen |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | Bryant Ranch Prepack | e6c47385-638a-41cd-93d9-b7ee205aa094 | 2026-05-14 | Boxed warning, Warnings, Adverse reactions | Oxycodone and Acetaminophen |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | Rhodes Pharmaceuticals LLC | 5999f3c3-3225-4d24-82cd-0b8d7a309587 | 2026-05-06 | Boxed warning, Warnings, Adverse reactions | Oxycodone and Acetaminophen |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | KVK-Tech, Inc. | f9cf218c-af5e-4249-aa3b-a8555ed02278 | 2026-05-04 | Boxed warning, Warnings, Adverse reactions | Oxycodone and Acetaminophen |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | Bryant Ranch Prepack | 639aba0b-1ef6-415f-9732-ebf52bcc1b86 | 2026-04-22 | Boxed warning, Warnings, Adverse reactions | Oxycodone and Acetaminophen |
| OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | Bryant Ranch Prepack | 3339d3bd-b416-4c5b-8984-0c376544d8a9 | 2026-04-13 | Boxed warning, Warnings, Adverse reactions | OXYCODONE AND ACETAMINOPHEN |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | Bryant Ranch Prepack | 79c3af61-19e7-40e5-bd20-2cea52f0bd3a | 2026-04-03 | Boxed warning, Warnings, Adverse reactions | Oxycodone and Acetaminophen |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | AvPAK | 7055acd5-1cbb-397e-e053-2a91aa0a3852 | 2026-01-21 | Boxed warning, Warnings, Adverse reactions | Oxycodone and Acetaminophen |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0228-2981 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2981 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2981 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2982 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2982 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2982 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2983 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2983 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2983 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Actavis Pharma, Inc. | ANDA | Current |
| 50436-2982 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Unit Dose Services | ANDA | Current |
| 50436-2982 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Unit Dose Services | ANDA | Current |
| 50436-2983 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Unit Dose Services | ANDA | Current |
| 50436-2983 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Unit Dose Services | ANDA | Current |
| 50436-3913 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Unit Dose Services | ANDA | Current |
| 50436-3913 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Unit Dose Services | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76325 | ORIG | 2023-11-03 |