Application 076636
- Type
- ANDA
- Sponsor
- ACTAVIS ELIZABETH
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 15MG | No | No |
| 002 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 30MG | No | No |
| 003 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076636-001 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | 2004-02-06 | ||
| A076636-002 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2004-02-06 | ||
| A076636-003 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2015-04-07 |
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 | A076636-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | 2004-02-06 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076636-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2004-02-06 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076636-003 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2015-04-07 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076636-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | 2004-02-06 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076636-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2004-02-06 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076636-003 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2015-04-07 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076636-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | 2004-02-06 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076636-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2004-02-06 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076636-003 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2015-04-07 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076636-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | 2004-02-06 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076636-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2004-02-06 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076636-003 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2015-04-07 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076636-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | 2004-02-06 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076636-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2004-02-06 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076636-003 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2015-04-07 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076636-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | 2004-02-06 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076636-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2004-02-06 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076636-003 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2015-04-07 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076636-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | 2004-02-06 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076636-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2004-02-06 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076636-003 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2015-04-07 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076636-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | 2004-02-06 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076636-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2004-02-06 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076636-003 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2015-04-07 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076636-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | 2004-02-06 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076636-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2004-02-06 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076636-003 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2015-04-07 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076636-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | 2004-02-06 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076636-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2004-02-06 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076636-003 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2015-04-07 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076636-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | 2004-02-06 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076636-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2004-02-06 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076636-003 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2015-04-07 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076636-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | 2004-02-06 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076636-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2004-02-06 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076636-003 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2015-04-07 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076636-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | 2004-02-06 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076636-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2004-02-06 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076636-003 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2015-04-07 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076636-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | 2004-02-06 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A076636-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A076636-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A076636-003 | AB | 1 | 74a2ff9319b5… |
| 2020-11-12 02:37 UTC | 2020-11 | A076636-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A076636-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A076636-003 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A076636-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A076636-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A076636-003 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A076636-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A076636-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A076636-003 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A076636-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A076636-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A076636-003 | AB | 1 | ea99ee380514… |
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 Hydrochloride | OXYCODONE HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | 3eddd18b-695a-4e53-a76c-f6779515b918 | 2024-09-12 | Boxed warning, Warnings, Adverse reactions | Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ef58f422-682e-6896-e053-2a95a90a1f2d | 2024-09-06 | Boxed warning, Warnings, Adverse reactions | Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | 1bcddbe1-c453-43ec-a822-9e993b885a5f | 2024-08-27 | Boxed warning, Warnings, Adverse reactions | Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | 261132f9-ab96-4901-a660-a80c3e0f9d86 | 2024-08-12 | Boxed warning, Warnings, Adverse reactions | Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE |
| Oxycodone hydrochloride | OXYCODONE HYDROCHLORIDE | Asclemed USA, Inc. | 1bb147d4-1ab6-dd70-e063-6394a90a67a8 | 2024-06-25 | Boxed warning, Warnings, Adverse reactions | Oxycodone hydrochloride OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE | Bryant Ranch Prepack | b2510d72-bf63-4c9d-ac5e-7bacd993fa10 | 2024-05-30 | Boxed warning, Warnings, Adverse reactions | Oxycodone Hydrochloride |
| Oxycodone Hydrochloride | OXYCODONE | Bryant Ranch Prepack | 232d44d2-3924-4d35-873c-d2aef75e9a41 | 2024-05-30 | Boxed warning, Warnings, Adverse reactions | Oxycodone Hydrochloride |
| Oxycodone Hydrochloride | OXYCODONE | Bryant Ranch Prepack | d248ceba-9492-4348-aa07-31c9c73a3620 | 2024-05-30 | Boxed warning, Warnings, Adverse reactions | Oxycodone Hydrochloride |
| Oxycodone Hydrochloride | OXYCODONE | Bryant Ranch Prepack | bc7fdf7e-ad4e-4a04-b35c-2233cc7e5f15 | 2024-05-30 | Boxed warning, Warnings, Adverse reactions | Oxycodone Hydrochloride |
| Oxycodone Hydrochloride | OXYCODONE | Bryant Ranch Prepack | 4e9e945d-5ffc-48de-99fa-3fb36c5bc2b9 | 2024-05-30 | Boxed warning, Warnings, Adverse reactions | Oxycodone Hydrochloride |
| Oxycodone Hydrochloride | OXYCODONE | Bryant Ranch Prepack | 9da42120-0214-45cb-bb98-9a7739e72d43 | 2024-05-29 | Boxed warning, Warnings, Adverse reactions | Oxycodone Hydrochloride |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 17f7946d-e889-b736-e063-6394a90a42e0 | 2024-05-08 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Lupin Pharmaceuticals,Inc. | 801cb437-c189-44f5-83eb-a51c365d8a6b | 2024-01-30 | Boxed warning, Warnings, Adverse reactions | Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Novel Laboratories, Inc. | 69410bf3-0d3a-41f9-b10a-c4ee3770f728 | 2023-12-09 | Boxed warning, Warnings, Adverse reactions | Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | QUAGEN PHARMACEUTICALS LLC | 391701e5-2035-43fa-91ce-d27a1af19492 | 2023-02-02 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Epic Pharma, LLC | cff1eee3-7c02-4f6c-acc5-1f6dcbab92c0 | 2022-12-29 | Boxed warning, Warnings, Adverse reactions | Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | XLCare Pharmaceuticals, Inc | e5c8e72d-4ac5-4ca3-9557-6a659d4d8338 | 2021-05-28 | Boxed warning, Warnings, Adverse reactions | Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Ascent Pharmaceuticals Inc | de96e2be-66d9-4bcb-a133-221ad32e09f1 | 2017-07-10 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE |
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 |
|---|---|---|---|---|---|
| 0228-2876 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2876 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2876 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2878 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2878 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2878 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2878 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2879 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2879 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2879 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2879 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 10544-005 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Blenheim Pharmacal, Inc. | ANDA | Current |
| 63629-4153 | oxycodone hydrochloride | oxycodone hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 68084-184 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-184 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-184 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-185 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-185 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-185 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | American Health Packaging | ANDA | Current |