Application 090177
- Type
- ANDA
- Sponsor
- MAYNE PHARMA 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 |
| 005 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 500MG;7.5MG | No | No |
| 006 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 650MG;10MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090177-001 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;2.5MG | TABLET / ORAL | 2008-10-20 | ||
| A090177-002 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;5MG | TABLET / ORAL | 2008-10-20 | ||
| A090177-003 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;7.5MG | TABLET / ORAL | 2008-10-20 | ||
| A090177-004 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;10MG | TABLET / ORAL | 2008-10-20 | ||
| A090177-005 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 500MG;7.5MG | TABLET / ORAL | 2008-10-20 | ||
| A090177-006 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 650MG;10MG | TABLET / ORAL | 2008-10-20 |
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 | A090177-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | 2008-10-20 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A090177-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | 2008-10-20 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A090177-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | 2008-10-20 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A090177-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | 2008-10-20 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A090177-005 | OXYCODONE AND ACETAMINOPHEN | 500MG;7.5MG | TABLET / ORAL | 2008-10-20 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A090177-006 | OXYCODONE AND ACETAMINOPHEN | 650MG;10MG | TABLET / ORAL | 2008-10-20 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090177-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | 2008-10-20 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090177-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | 2008-10-20 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090177-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | 2008-10-20 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090177-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | 2008-10-20 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090177-005 | OXYCODONE AND ACETAMINOPHEN | 500MG;7.5MG | TABLET / ORAL | 2008-10-20 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090177-006 | OXYCODONE AND ACETAMINOPHEN | 650MG;10MG | TABLET / ORAL | 2008-10-20 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090177-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | 2008-10-20 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090177-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | 2008-10-20 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090177-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | 2008-10-20 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090177-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | 2008-10-20 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090177-005 | OXYCODONE AND ACETAMINOPHEN | 500MG;7.5MG | TABLET / ORAL | 2008-10-20 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090177-006 | OXYCODONE AND ACETAMINOPHEN | 650MG;10MG | TABLET / ORAL | 2008-10-20 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090177-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | 2008-10-20 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090177-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | 2008-10-20 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090177-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | 2008-10-20 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090177-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | 2008-10-20 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090177-005 | OXYCODONE AND ACETAMINOPHEN | 500MG;7.5MG | TABLET / ORAL | 2008-10-20 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090177-006 | OXYCODONE AND ACETAMINOPHEN | 650MG;10MG | TABLET / ORAL | 2008-10-20 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090177-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | 2008-10-20 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090177-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | 2008-10-20 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090177-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | 2008-10-20 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090177-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | 2008-10-20 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090177-005 | OXYCODONE AND ACETAMINOPHEN | 500MG;7.5MG | TABLET / ORAL | 2008-10-20 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090177-006 | OXYCODONE AND ACETAMINOPHEN | 650MG;10MG | TABLET / ORAL | 2008-10-20 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090177-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | 2008-10-20 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090177-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | 2008-10-20 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090177-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | 2008-10-20 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090177-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | 2008-10-20 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090177-005 | OXYCODONE AND ACETAMINOPHEN | 500MG;7.5MG | TABLET / ORAL | 2008-10-20 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090177-006 | OXYCODONE AND ACETAMINOPHEN | 650MG;10MG | TABLET / ORAL | 2008-10-20 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090177-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | 2008-10-20 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090177-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | 2008-10-20 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090177-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | 2008-10-20 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090177-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | 2008-10-20 | b8a1b40f171c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090177-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090177-002 | AA | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090177-003 | AA | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090177-004 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A090177-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A090177-002 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A090177-003 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A090177-004 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A090177-001 | AA | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A090177-002 | AA | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A090177-003 | AA | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A090177-004 | AA | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A090177-001 | AA | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A090177-002 | AA | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A090177-003 | AA | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A090177-004 | AA | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A090177-001 | AA | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A090177-002 | AA | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A090177-003 | AA | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A090177-004 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A090177-001 | AA | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A090177-002 | AA | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A090177-003 | AA | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A090177-004 | AA | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090177-001 | AA | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090177-002 | AA | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090177-003 | AA | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090177-004 | AA | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A090177-001 | AA | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A090177-002 | AA | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A090177-003 | AA | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A090177-004 | AA | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A090177-001 | AA | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A090177-002 | AA | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A090177-003 | AA | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A090177-004 | AA | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A090177-001 | AA | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A090177-002 | AA | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A090177-003 | AA | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A090177-004 | AA | 1 | c0c555d07b60… |
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 | Proficient Rx LP | df97ea5a-51df-453b-b1b4-edc74c718ee7 | 2019-10-01 | Boxed warning, Warnings, Adverse reactions | Oxycodone and Acetaminophen |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | Camber Pharmaceuticals, Inc. | 2a49ee34-6f1d-4ed3-8daa-343723d2a2be | 2018-02-20 | Boxed warning, Warnings, Adverse reactions | Oxycodone and Acetaminophen |
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 |
|---|---|---|---|---|---|
| 67296-1401 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1401 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | RedPharm Drug, Inc. | ANDA | Current |
| 68308-405 | Oxycodone and Acetaminophen | Oxycodone Hydrochloride and Acetaminophen | Mayne Pharma Inc. | ANDA | Current |
| 68308-405 | Oxycodone and Acetaminophen | Oxycodone Hydrochloride and Acetaminophen | Mayne Pharma Inc. | ANDA | Current |
| 68308-475 | Oxycodone and Acetaminophen | Oxycodone Hydrochloride and Acetaminophen | Mayne Pharma Inc. | ANDA | Current |
| 68308-475 | Oxycodone and Acetaminophen | Oxycodone Hydrochloride and Acetaminophen | Mayne Pharma Inc. | ANDA | Current |
| 68308-475 | Oxycodone and Acetaminophen | Oxycodone Hydrochloride and Acetaminophen | Mayne Pharma Inc. | ANDA | Current |
| 68308-475 | Oxycodone and Acetaminophen | Oxycodone Hydrochloride and Acetaminophen | Mayne Pharma Inc. | ANDA | Current |
| 68308-475 | Oxycodone and Acetaminophen | Oxycodone Hydrochloride and Acetaminophen | Mayne Pharma Inc. | ANDA | Current |
| 68308-480 | Oxycodone and Acetaminophen | Oxycodone Hydrochloride and Acetaminophen | Mayne Pharma Inc. | ANDA | Current |
| 68308-480 | Oxycodone and Acetaminophen | Oxycodone Hydrochloride and Acetaminophen | Mayne Pharma Inc. | ANDA | Current |
| 68308-480 | Oxycodone and Acetaminophen | Oxycodone Hydrochloride and Acetaminophen | Mayne Pharma Inc. | ANDA | Current |
| 68308-480 | Oxycodone and Acetaminophen | Oxycodone Hydrochloride and Acetaminophen | Mayne Pharma Inc. | ANDA | Current |
| 68308-480 | Oxycodone and Acetaminophen | Oxycodone Hydrochloride and Acetaminophen | Mayne Pharma Inc. | ANDA | Current |
| 68308-840 | Oxycodone and Acetaminophen | Oxycodone Hydrochloride and Acetaminophen | Mayne Pharma Inc. | ANDA | Current |
| 68308-841 | Oxycodone and Acetaminophen | Oxycodone Hydrochloride and Acetaminophen | Mayne Pharma Inc. | ANDA | Current |
| 68308-841 | Oxycodone and Acetaminophen | Oxycodone Hydrochloride and Acetaminophen | Mayne Pharma Inc. | ANDA | Current |
| 68308-842 | Oxycodone and Acetaminophen | Oxycodone Hydrochloride and Acetaminophen | Mayne Pharma Inc. | ANDA | Current |
| 68308-843 | Oxycodone and Acetaminophen | Oxycodone Hydrochloride and Acetaminophen | Mayne Pharma Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76108 | ORIG | 2023-11-02 |