Application 204021
- Type
- ANDA
- Sponsor
- NOVEL LABS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
| 002 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
| 003 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 15MG | No | No |
| 004 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 20MG | No | No |
| 005 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 30MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A204021-001 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2017-06-12 | ||
| A204021-002 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2017-06-12 | ||
| A204021-003 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | 2017-06-12 | ||
| A204021-004 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | 2017-06-12 | ||
| A204021-005 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2017-06-12 |
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 | A204021-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2017-06-12 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A204021-002 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2017-06-12 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A204021-003 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | 2017-06-12 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A204021-004 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | 2017-06-12 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A204021-005 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2017-06-12 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A204021-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2017-06-12 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A204021-002 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2017-06-12 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A204021-003 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | 2017-06-12 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A204021-004 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | 2017-06-12 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A204021-005 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2017-06-12 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204021-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2017-06-12 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204021-002 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2017-06-12 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204021-003 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | 2017-06-12 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204021-004 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | 2017-06-12 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204021-005 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2017-06-12 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204021-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2017-06-12 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204021-002 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2017-06-12 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204021-003 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | 2017-06-12 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204021-004 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | 2017-06-12 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204021-005 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2017-06-12 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204021-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2017-06-12 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204021-002 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2017-06-12 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204021-003 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | 2017-06-12 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204021-004 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | 2017-06-12 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204021-005 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2017-06-12 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204021-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2017-06-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204021-002 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2017-06-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204021-003 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2017-06-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204021-004 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2017-06-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204021-005 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2017-06-12 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204021-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2017-06-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204021-002 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2017-06-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204021-003 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2017-06-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204021-004 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2017-06-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204021-005 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2017-06-12 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204021-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2017-06-12 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204021-002 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2017-06-12 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204021-003 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2017-06-12 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204021-004 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2017-06-12 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204021-005 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2017-06-12 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204021-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204021-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204021-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204021-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204021-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204021-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204021-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204021-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204021-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204021-005 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204021-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204021-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204021-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204021-004 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204021-005 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204021-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204021-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204021-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204021-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204021-005 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204021-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204021-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204021-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204021-004 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204021-005 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A204021-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A204021-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A204021-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A204021-004 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A204021-005 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204021-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204021-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204021-003 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204021-004 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204021-005 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204021-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204021-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204021-003 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204021-004 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204021-005 | AB | 1 | 301d65b070ca… |
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 | DIRECT RX | a8206207-ad09-83df-e053-2995a90a78b7 | 2025-06-05 | Boxed warning, Warnings, Adverse reactions | 204021 ANDA204021 72189-095 |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Lupin Pharmaceuticals,Inc. | 801cb437-c189-44f5-83eb-a51c365d8a6b | 2024-01-30 | Boxed warning, Warnings, Adverse reactions | 204021 ANDA204021 43386-432 43386-431 43386-434 43386-430 43386-433 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 40032-430 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Novel Laboratories, Inc. | ANDA | Current |
| 40032-431 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Novel Laboratories, Inc. | ANDA | Current |
| 40032-432 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Novel Laboratories, Inc. | ANDA | Current |
| 40032-433 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Novel Laboratories, Inc. | ANDA | Current |
| 40032-434 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Novel Laboratories, Inc. | ANDA | Current |
| 43386-430 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Lupin Pharmaceuticals,Inc. | ANDA | Current |
| 43386-430 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Lupin Pharmaceuticals,Inc. | ANDA | Current |
| 43386-431 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Lupin Pharmaceuticals,Inc. | ANDA | Current |
| 43386-431 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Lupin Pharmaceuticals,Inc. | ANDA | Current |
| 43386-432 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Lupin Pharmaceuticals,Inc. | ANDA | Current |
| 43386-432 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Lupin Pharmaceuticals,Inc. | ANDA | Current |
| 43386-433 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Lupin Pharmaceuticals,Inc. | ANDA | Current |
| 43386-433 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Lupin Pharmaceuticals,Inc. | ANDA | Current |
| 43386-434 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Lupin Pharmaceuticals,Inc. | ANDA | Current |
| 43386-434 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Lupin Pharmaceuticals,Inc. | ANDA | Current |
| 51407-529 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-529 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-530 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-531 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-532 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-533 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 72189-095 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 72189-095 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 72189-095 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | DIRECT RX | ANDA | Current |