Application 201448
- Type
- ANDA
- Sponsor
- NOSTRUM LABS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | SOLUTION;ORAL | 325MG/5ML;5MG/5ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A201448-001 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG/5ML;5MG/5ML | SOLUTION / ORAL | 2021-08-26 |
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 | A201448-001 | OXYCODONE AND ACETAMINOPHEN | 325MG/5ML;5MG/5ML | SOLUTION / ORAL | 2021-08-26 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A201448-001 | OXYCODONE AND ACETAMINOPHEN | 325MG/5ML;5MG/5ML | SOLUTION / ORAL | 2021-08-26 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A201448-001 | OXYCODONE AND ACETAMINOPHEN | 325MG/5ML;5MG/5ML | SOLUTION / ORAL | 2021-08-26 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201448-001 | OXYCODONE AND ACETAMINOPHEN | 325MG/5ML;5MG/5ML | SOLUTION / ORAL | 2021-08-26 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A201448-001 | OXYCODONE AND ACETAMINOPHEN | 325MG/5ML;5MG/5ML | SOLUTION / ORAL | AA | 2021-08-26 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201448-001 | OXYCODONE AND ACETAMINOPHEN | 325MG/5ML;5MG/5ML | SOLUTION / ORAL | AA | 2021-08-26 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201448-001 | OXYCODONE AND ACETAMINOPHEN | 325MG/5ML;5MG/5ML | SOLUTION / ORAL | AA | 2021-08-26 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201448-001 | OXYCODONE AND ACETAMINOPHEN | 325MG/5ML;5MG/5ML | SOLUTION / ORAL | AA | 2021-08-26 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201448-001 | OXYCODONE AND ACETAMINOPHEN | 325MG/5ML;5MG/5ML | SOLUTION / ORAL | AA | 2021-08-26 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201448-001 | OXYCODONE AND ACETAMINOPHEN | 325MG/5ML;5MG/5ML | SOLUTION / ORAL | AA | 2021-08-26 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201448-001 | OXYCODONE AND ACETAMINOPHEN | 325MG/5ML;5MG/5ML | SOLUTION / ORAL | AA | 2021-08-26 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A201448-001 | OXYCODONE AND ACETAMINOPHEN | 325MG/5ML;5MG/5ML | SOLUTION / ORAL | AA | 2021-08-26 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A201448-001 | OXYCODONE AND ACETAMINOPHEN | 325MG/5ML;5MG/5ML | SOLUTION / ORAL | AA | 2021-08-26 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A201448-001 | OXYCODONE AND ACETAMINOPHEN | 325MG/5ML;5MG/5ML | SOLUTION / ORAL | AA | 2021-08-26 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A201448-001 | OXYCODONE AND ACETAMINOPHEN | 325MG/5ML;5MG/5ML | SOLUTION / ORAL | AA | 2021-08-26 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A201448-001 | OXYCODONE AND ACETAMINOPHEN | 325MG/5ML;5MG/5ML | SOLUTION / ORAL | AA | 2021-08-26 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A201448-001 | OXYCODONE AND ACETAMINOPHEN | 325MG/5ML;5MG/5ML | SOLUTION / ORAL | AA | 2021-08-26 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A201448-001 | OXYCODONE AND ACETAMINOPHEN | 325MG/5ML;5MG/5ML | SOLUTION / ORAL | AA | 2021-08-26 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A201448-001 | OXYCODONE AND ACETAMINOPHEN | 325MG/5ML;5MG/5ML | SOLUTION / ORAL | AA | 2021-08-26 | 4b0b4de00fa7… | |
| 2022-03-09 01:35 UTC | 2022-03 | A201448-001 | OXYCODONE AND ACETAMINOPHEN | 325MG/5ML;5MG/5ML | SOLUTION / ORAL | AA | 2021-08-26 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A201448-001 | OXYCODONE AND ACETAMINOPHEN | 325MG/5ML;5MG/5ML | SOLUTION / ORAL | AA | 2021-08-26 | 782e0a99824c… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A201448-001 | OXYCODONE AND ACETAMINOPHEN | 325MG/5ML;5MG/5ML | SOLUTION / ORAL | AA | 2021-08-26 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A201448-001 | OXYCODONE AND ACETAMINOPHEN | 325MG/5ML;5MG/5ML | SOLUTION / ORAL | AA | 2021-08-26 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A201448-001 | OXYCODONE AND ACETAMINOPHEN | 325MG/5ML;5MG/5ML | SOLUTION / ORAL | AA | 2021-08-26 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A201448-001 | OXYCODONE AND ACETAMINOPHEN | 325MG/5ML;5MG/5ML | SOLUTION / ORAL | AA | 2021-08-26 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A201448-001 | OXYCODONE AND ACETAMINOPHEN | 325MG/5ML;5MG/5ML | SOLUTION / ORAL | AA | 2021-08-26 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A201448-001 | OXYCODONE AND ACETAMINOPHEN | 325MG/5ML;5MG/5ML | SOLUTION / ORAL | AA | 2021-08-26 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A201448-001 | OXYCODONE AND ACETAMINOPHEN | 325MG/5ML;5MG/5ML | SOLUTION / ORAL | AA | 2021-08-26 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A201448-001 | OXYCODONE AND ACETAMINOPHEN | 325MG/5ML;5MG/5ML | SOLUTION / ORAL | AA | 2021-08-26 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A201448-001 | OXYCODONE AND ACETAMINOPHEN | 325MG/5ML;5MG/5ML | SOLUTION / ORAL | AA | 2021-08-26 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A201448-001 | OXYCODONE AND ACETAMINOPHEN | 325MG/5ML;5MG/5ML | SOLUTION / ORAL | AA | 2021-08-26 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A201448-001 | OXYCODONE AND ACETAMINOPHEN | 325MG/5ML;5MG/5ML | SOLUTION / ORAL | AA | 2021-08-26 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A201448-001 | OXYCODONE AND ACETAMINOPHEN | 325MG/5ML;5MG/5ML | SOLUTION / ORAL | AA | 2021-08-26 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A201448-001 | OXYCODONE AND ACETAMINOPHEN | 325MG/5ML;5MG/5ML | SOLUTION / ORAL | AA | 2021-08-26 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A201448-001 | OXYCODONE AND ACETAMINOPHEN | 325MG/5ML;5MG/5ML | SOLUTION / ORAL | 2021-08-26 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-08-23 18:47 UTC | 2025-08 | A201448-001 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201448-001 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201448-001 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201448-001 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201448-001 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201448-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201448-001 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A201448-001 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A201448-001 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A201448-001 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A201448-001 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A201448-001 | AA | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A201448-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A201448-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A201448-001 | AA | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | A201448-001 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A201448-001 | AA | 1 | 782e0a99824c… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A201448-001 | AA | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A201448-001 | AA | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A201448-001 | AA | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A201448-001 | AA | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A201448-001 | AA | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A201448-001 | AA | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A201448-001 | AA | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A201448-001 | AA | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A201448-001 | AA | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A201448-001 | AA | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A201448-001 | AA | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A201448-001 | AA | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A201448-001 | AA | 1 | cb3db0bc1861… |
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 | NuCare Pharmaceuticals,Inc. | 9e4024f4-0f60-dfef-e053-2995a90ac366 | 2024-06-20 | Boxed warning, Warnings, Adverse reactions | Oxycodone and Acetaminophen |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | NuCare Pharmaceuticals,Inc. | 925f9787-3d1c-0189-e053-2a95a90a2972 | 2024-06-19 | Boxed warning, Warnings, Adverse reactions | Oxycodone and Acetaminophen |
| OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | Bryant Ranch Prepack | 4a873428-bb5a-4e48-9185-2a27f289110d | 2024-05-31 | Boxed warning, Warnings, Adverse reactions | OXYCODONE AND ACETAMINOPHEN |
| OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | Bryant Ranch Prepack | 88d05136-7b04-4b25-af1c-6bc72fdbcbd7 | 2024-05-31 | Boxed warning, Warnings, Adverse reactions | OXYCODONE AND ACETAMINOPHEN |
| OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | Bryant Ranch Prepack | 96173ce4-4836-43ae-9797-5246f830643a | 2024-05-31 | Boxed warning, Warnings, Adverse reactions | OXYCODONE AND ACETAMINOPHEN |
| OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | Bryant Ranch Prepack | 3791abd3-fcdf-4c8d-b46d-db6e5c805770 | 2024-05-30 | Boxed warning, Warnings, Adverse reactions | OXYCODONE AND ACETAMINOPHEN |
| OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | Bryant Ranch Prepack | 0c85d1b8-ea42-421d-a305-4d338b47150f | 2024-05-30 | Boxed warning, Warnings, Adverse reactions | OXYCODONE AND ACETAMINOPHEN |
| OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | Bryant Ranch Prepack | 71b1a9be-3231-4b09-a195-d5893104bd4a | 2024-05-23 | Boxed warning, Warnings, Adverse reactions | OXYCODONE AND ACETAMINOPHEN |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | Bryant Ranch Prepack | 4da8a7bd-0d2e-452c-afb5-fed4e230a9bd | 2024-04-08 | Boxed warning, Warnings, Adverse reactions | Oxycodone and Acetaminophen |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | Lupin Pharmaceuticals,Inc. | 916ff456-a27e-49dc-a312-274126a8c30c | 2024-02-29 | Boxed warning, Warnings, Adverse reactions | Oxycodone and Acetaminophen |
| OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | XLCare Pharmaceuticals, Inc. | 7f3c6dd7-6bc8-450e-aded-997f9cf63a8f | 2024-02-12 | Boxed warning, Warnings, Adverse reactions | OXYCODONE AND ACETAMINOPHEN |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | Proficient Rx LP | 78933d4a-d78a-43bc-9052-a032901ee050 | 2022-11-01 | Boxed warning, Warnings, Adverse reactions | Oxycodone and Acetaminophen |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | Proficient Rx LP | 5df7c033-0f31-45bc-8c34-3da45635e66d | 2022-11-01 | Boxed warning, Warnings, Adverse reactions | Oxycodone and Acetaminophen |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | Proficient Rx LP | ad03068c-1af4-46ce-bdea-c2745b1c1e52 | 2022-10-01 | Boxed warning, Warnings, Adverse reactions | Oxycodone and Acetaminophen |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | Proficient Rx LP | 484a4323-0758-439d-844f-f04d7e5ef6f3 | 2022-08-01 | Boxed warning, Warnings, Adverse reactions | Oxycodone and Acetaminophen |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | Asclemed USA, Inc. | 3e89f02d-b6e7-4641-82d4-f756518a8914 | 2022-05-05 | Boxed warning, Warnings, Adverse reactions | Oxycodone and Acetaminophen |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | Asclemed USA, Inc. | 0dcb491a-54e8-486b-9575-788525a178cf | 2021-08-28 | Boxed warning, Warnings, Adverse reactions | Oxycodone and Acetaminophen |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | Proficient Rx LP | dd4dbe5b-8d07-4a96-a78d-2f20da761dad | 2019-11-01 | Boxed warning, Warnings, Adverse reactions | Oxycodone and Acetaminophen |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | Proficient Rx LP | 6253b3ae-bb52-4532-8d1f-756c0b1577c7 | 2019-11-01 | Warnings, Adverse reactions | Oxycodone and Acetaminophen |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | Proficient Rx LP | 0233de1c-466b-4842-8604-6d879aa36a4b | 2019-11-01 | 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 |
|---|---|---|---|---|---|
| 29033-405 | Oxycodone Hydrochloride and Acetaminophen | Oxycodone Hydrochloride and Acetaminophen | Nostrum Laboratories, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76477 | ORIG | 2023-11-07 |