Application 040608
- Type
- ANDA
- Sponsor
- MIKART
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 300MG;2.5MG | No | Yes |
| 002 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 300MG;5MG | No | Yes |
| 003 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 300MG;7.5MG | No | Yes |
| 004 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 300MG;10MG | No | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040608-001 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 300MG;2.5MG | TABLET / ORAL | RS | 2005-12-30 | |
| A040608-002 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 300MG;5MG | TABLET / ORAL | RS | 2005-12-30 | |
| A040608-003 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 300MG;7.5MG | TABLET / ORAL | RS | 2005-12-30 | |
| A040608-004 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 300MG;10MG | TABLET / ORAL | RS | 2005-12-30 |
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 | A040608-001 | OXYCODONE AND ACETAMINOPHEN | 300MG;2.5MG | TABLET / ORAL | RS | 2005-12-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A040608-002 | OXYCODONE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | RS | 2005-12-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A040608-003 | OXYCODONE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | RS | 2005-12-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A040608-004 | OXYCODONE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | RS | 2005-12-30 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040608-001 | OXYCODONE AND ACETAMINOPHEN | 300MG;2.5MG | TABLET / ORAL | RS | 2005-12-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040608-002 | OXYCODONE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | RS | 2005-12-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040608-003 | OXYCODONE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | RS | 2005-12-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040608-004 | OXYCODONE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | RS | 2005-12-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040608-001 | OXYCODONE AND ACETAMINOPHEN | 300MG;2.5MG | TABLET / ORAL | RS | 2005-12-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040608-002 | OXYCODONE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | RS | 2005-12-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040608-003 | OXYCODONE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | RS | 2005-12-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040608-004 | OXYCODONE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | RS | 2005-12-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040608-001 | OXYCODONE AND ACETAMINOPHEN | 300MG;2.5MG | TABLET / ORAL | RS | 2005-12-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040608-002 | OXYCODONE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | RS | 2005-12-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040608-003 | OXYCODONE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | RS | 2005-12-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040608-004 | OXYCODONE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | RS | 2005-12-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040608-001 | OXYCODONE AND ACETAMINOPHEN | 300MG;2.5MG | TABLET / ORAL | RS | 2005-12-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040608-002 | OXYCODONE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | RS | 2005-12-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040608-003 | OXYCODONE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | RS | 2005-12-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040608-004 | OXYCODONE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | RS | 2005-12-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040608-001 | OXYCODONE AND ACETAMINOPHEN | 300MG;2.5MG | TABLET / ORAL | RS | 2005-12-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040608-002 | OXYCODONE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | RS | 2005-12-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040608-003 | OXYCODONE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | RS | 2005-12-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040608-004 | OXYCODONE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | RS | 2005-12-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040608-001 | OXYCODONE AND ACETAMINOPHEN | 300MG;2.5MG | TABLET / ORAL | RS | 2005-12-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040608-002 | OXYCODONE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | RS | 2005-12-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040608-003 | OXYCODONE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | RS | 2005-12-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040608-004 | OXYCODONE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | RS | 2005-12-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040608-001 | OXYCODONE AND ACETAMINOPHEN | 300MG;2.5MG | TABLET / ORAL | RS | 2005-12-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040608-002 | OXYCODONE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | RS | 2005-12-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040608-003 | OXYCODONE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | RS | 2005-12-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040608-004 | OXYCODONE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | RS | 2005-12-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040608-001 | OXYCODONE AND ACETAMINOPHEN | 300MG;2.5MG | TABLET / ORAL | RS | 2005-12-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040608-002 | OXYCODONE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | RS | 2005-12-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040608-003 | OXYCODONE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | RS | 2005-12-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040608-004 | OXYCODONE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | RS | 2005-12-30 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040608-001 | OXYCODONE AND ACETAMINOPHEN | 300MG;2.5MG | TABLET / ORAL | RS | 2005-12-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040608-002 | OXYCODONE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | RS | 2005-12-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040608-003 | OXYCODONE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | RS | 2005-12-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040608-004 | OXYCODONE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | RS | 2005-12-30 | d8e5a09893c0… |
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 |
|---|---|---|---|---|---|---|
| Nalocet | OXYCODONE AND ACETAMINOPHEN | Forte Bio-Pharma LLC | f5f7dfca-a5c7-4445-8a5e-9ec62f33f5be | 2026-08-06 | Boxed warning, Warnings, Adverse reactions | 040608 ANDA040608 72245-193 |
| oxycodone and acetaminophen | OXYCODONE AND ACETAMINOPHEN | FH2 Pharma LLC | 88d97caf-bcf5-3cde-e053-2995a90acf4a | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | 040608 ANDA040608 72887-682 72887-681 72887-683 72887-193 |
| Prolate | OXYCODONE AND ACETAMINOPHEN | Forte Bio-Pharma LLC | 9cbbfa94-37b9-9652-e053-2995a90a736b | 2026-05-19 | Boxed warning, Warnings, Adverse reactions | 040608 ANDA040608 72245-681 72245-683 72245-682 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 24090-681 | Primlev | oxycodone and acetaminophen | Akrimax Pharmaceuticals, LLC | ANDA | Current |
| 24090-681 | Primlev | oxycodone and acetaminophen | Akrimax Pharmaceuticals, LLC | ANDA | Current |
| 24090-682 | Primlev | oxycodone and acetaminophen | Akrimax Pharmaceuticals, LLC | ANDA | Current |
| 24090-682 | Primlev | oxycodone and acetaminophen | Akrimax Pharmaceuticals, LLC | ANDA | Current |
| 24090-683 | Primlev | oxycodone and acetaminophen | Akrimax Pharmaceuticals, LLC | ANDA | Current |
| 24090-683 | Primlev | oxycodone and acetaminophen | Akrimax Pharmaceuticals, LLC | ANDA | Current |
| 46672-193 | oxycodone and acetaminophen | oxycodone and acetaminophen | Mikart, LLC | ANDA | Current |
| 46672-193 | oxycodone and acetaminophen | oxycodone and acetaminophen | Mikart, LLC | ANDA | Current |
| 46672-193 | oxycodone and acetaminophen | oxycodone and acetaminophen | Mikart, LLC | ANDA | Current |
| 46672-193 | oxycodone and acetaminophen | oxycodone and acetaminophen | Mikart, LLC | ANDA | Current |
| 46672-194 | oxycodone and acetaminophen | oxycodone and acetaminophen | Mikart, LLC | ANDA | Current |
| 46672-194 | oxycodone and acetaminophen | oxycodone and acetaminophen | Mikart, LLC | ANDA | Current |
| 46672-194 | oxycodone and acetaminophen | oxycodone and acetaminophen | Mikart, LLC | ANDA | Current |
| 46672-194 | oxycodone and acetaminophen | oxycodone and acetaminophen | Mikart, LLC | ANDA | Current |
| 46672-195 | oxycodone and acetaminophen | oxycodone and acetaminophen | Mikart, LLC | ANDA | Current |
| 46672-195 | oxycodone and acetaminophen | oxycodone and acetaminophen | Mikart, LLC | ANDA | Current |
| 46672-195 | oxycodone and acetaminophen | oxycodone and acetaminophen | Mikart, LLC | ANDA | Current |
| 46672-195 | oxycodone and acetaminophen | oxycodone and acetaminophen | Mikart, LLC | ANDA | Current |
| 46672-196 | oxycodone and acetaminophen | oxycodone and acetaminophen | Mikart, LLC | ANDA | Current |
| 46672-196 | oxycodone and acetaminophen | oxycodone and acetaminophen | Mikart, LLC | ANDA | Current |
| 46672-196 | oxycodone and acetaminophen | oxycodone and acetaminophen | Mikart, LLC | ANDA | Current |
| 46672-196 | oxycodone and acetaminophen | oxycodone and acetaminophen | Mikart, LLC | ANDA | Current |
| 72245-193 | Nalocet | oxycodone and acetaminophen | Forte Bio-Pharma LLC | ANDA | Current |
| 72245-193 | Nalocet | oxycodone and acetaminophen | Forte Bio-Pharma LLC | ANDA | Current |
| 72245-193 | Nalocet | oxycodone and acetaminophen | Forte Bio-Pharma LLC | ANDA | Current |
| 72245-681 | Prolate | oxycodone and acetaminophen | Forte Bio-Pharma LLC | ANDA | Current |
| 72245-681 | Prolate | oxycodone and acetaminophen | Forte Bio-Pharma LLC | ANDA | Current |
| 72245-681 | Prolate | oxycodone and acetaminophen | Forte Bio-Pharma LLC | ANDA | Current |
| 72245-681 | Prolate | oxycodone and acetaminophen | Forte Bio-Pharma LLC | ANDA | Current |
| 72245-682 | Prolate | oxycodone and acetaminophen | Forte Bio-Pharma LLC | ANDA | Current |
| 72245-682 | Prolate | oxycodone and acetaminophen | Forte Bio-Pharma LLC | ANDA | Current |
| 72245-682 | Prolate | oxycodone and acetaminophen | Forte Bio-Pharma LLC | ANDA | Current |
| 72245-682 | Prolate | oxycodone and acetaminophen | Forte Bio-Pharma LLC | ANDA | Current |
| 72245-683 | Prolate | oxycodone and acetaminophen | Forte Bio-Pharma LLC | ANDA | Current |
| 72245-683 | Prolate | oxycodone and acetaminophen | Forte Bio-Pharma LLC | ANDA | Current |
| 72245-683 | Prolate | oxycodone and acetaminophen | Forte Bio-Pharma LLC | ANDA | Current |
| 72245-683 | Prolate | oxycodone and acetaminophen | Forte Bio-Pharma LLC | ANDA | Current |
| 72887-193 | oxycodone and acetaminophen | oxycodone and acetaminophen | FH2 Pharma LLC | ANDA | Current |
| 72887-193 | oxycodone and acetaminophen | oxycodone and acetaminophen | FH2 Pharma LLC | ANDA | Current |
| 72887-193 | oxycodone and acetaminophen | oxycodone and acetaminophen | FH2 Pharma LLC | ANDA | Current |
| 72887-193 | oxycodone and acetaminophen | oxycodone and acetaminophen | FH2 Pharma LLC | ANDA | Current |
| 72887-193 | oxycodone and acetaminophen | oxycodone and acetaminophen | FH2 Pharma LLC | ANDA | Current |
| 72887-193 | oxycodone and acetaminophen | oxycodone and acetaminophen | FH2 Pharma LLC | ANDA | Current |
| 72887-681 | oxycodone and acetaminophen | oxycodone and acetaminophen tablets | FH2 Pharma LLC | ANDA | Current |
| 72887-681 | oxycodone and acetaminophen | oxycodone and acetaminophen tablets | FH2 Pharma LLC | ANDA | Current |
| 72887-681 | oxycodone and acetaminophen | oxycodone and acetaminophen tablets | FH2 Pharma LLC | ANDA | Current |
| 72887-681 | oxycodone and acetaminophen | oxycodone and acetaminophen tablets | FH2 Pharma LLC | ANDA | Current |
| 72887-681 | oxycodone and acetaminophen | oxycodone and acetaminophen tablets | FH2 Pharma LLC | ANDA | Current |
| 72887-682 | oxycodone and acetaminophen | oxycodone and acetaminophen | FH2 Pharma LLC | ANDA | Current |
| 72887-682 | oxycodone and acetaminophen | oxycodone and acetaminophen | FH2 Pharma LLC | ANDA | Current |
| 72887-682 | oxycodone and acetaminophen | oxycodone and acetaminophen | FH2 Pharma LLC | ANDA | Current |
| 72887-682 | oxycodone and acetaminophen | oxycodone and acetaminophen | FH2 Pharma LLC | ANDA | Current |
| 72887-683 | oxycodone and acetaminophen | oxycodone and acetaminophen tablets | FH2 Pharma LLC | ANDA | Current |
| 72887-683 | oxycodone and acetaminophen | oxycodone and acetaminophen tablets | FH2 Pharma LLC | ANDA | Current |
| 72887-683 | oxycodone and acetaminophen | oxycodone and acetaminophen tablets | FH2 Pharma LLC | ANDA | Current |
| 72887-683 | oxycodone and acetaminophen | oxycodone and acetaminophen tablets | FH2 Pharma LLC | ANDA | Current |
| 72887-683 | oxycodone and acetaminophen | oxycodone and acetaminophen tablets | FH2 Pharma LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76121 | ORIG | 2023-11-03 |