Application 091393
- Type
- ANDA
- Sponsor
- AVANTHI 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 | Yes |
| 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 |
|---|---|---|---|---|---|---|---|
| A091393-001 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2009-08-31 | |
| A091393-002 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | RS | 2009-08-31 |
| A091393-003 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2009-08-31 | |
| A091393-004 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2009-08-31 | |
| A091393-005 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2009-08-31 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A091393-001 | AB |
| A091393-002 | AB |
| A091393-003 | AB |
| A091393-004 | AB |
| A091393-005 | AB |
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 | A091393-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2009-08-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A091393-002 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | RS | 2009-08-31 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A091393-003 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2009-08-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A091393-004 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2009-08-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A091393-005 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2009-08-31 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091393-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2009-08-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091393-002 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | RS | 2009-08-31 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091393-003 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2009-08-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091393-004 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2009-08-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091393-005 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2009-08-31 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091393-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2009-08-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091393-002 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | RS | 2009-08-31 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091393-003 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2009-08-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091393-004 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2009-08-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091393-005 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2009-08-31 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091393-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2009-08-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091393-002 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | RS | 2009-08-31 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091393-003 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2009-08-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091393-004 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2009-08-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091393-005 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2009-08-31 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091393-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2009-08-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091393-002 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | RS | 2009-08-31 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091393-003 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2009-08-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091393-004 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2009-08-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091393-005 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2009-08-31 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091393-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2009-08-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091393-002 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | RS | 2009-08-31 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091393-003 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2009-08-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091393-004 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2009-08-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091393-005 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2009-08-31 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091393-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2009-08-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091393-002 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | RS | 2009-08-31 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091393-003 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2009-08-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091393-004 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2009-08-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091393-005 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2009-08-31 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091393-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2009-08-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091393-002 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | RS | 2009-08-31 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091393-003 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2009-08-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091393-004 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2009-08-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091393-005 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2009-08-31 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A091393-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A091393-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A091393-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A091393-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A091393-005 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A091393-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091393-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091393-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091393-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091393-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091393-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091393-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091393-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091393-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091393-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A091393-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091393-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091393-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091393-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091393-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091393-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091393-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091393-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091393-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091393-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091393-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091393-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091393-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091393-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091393-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091393-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091393-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091393-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091393-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091393-005 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091393-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091393-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091393-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091393-004 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091393-005 | AB | 1 | 2680178bc6a6… |
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 | St. Mary's Medical Park Pharmacy | 3ccf459a-fb11-e137-e063-6394a90a5a80 | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | 091393 ANDA091393 |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | 685d9709-028e-4422-bf0c-fde577b718a2 | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | 091393 ANDA091393 71335-1245 |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | KVK-TECH,INC | e73897d6-b920-4300-a564-5dbc9c8e9fe9 | 2026-06-04 | Boxed warning, Warnings, Adverse reactions | 091393 ANDA091393 10702-009 10702-008 10702-056 10702-057 10702-018 |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | ST. MARY'S MEDICAL PARK PHARMACY | 424fdfc7-1c92-2e62-e063-6394a90a136b | 2026-05-19 | Boxed warning, Warnings, Adverse reactions | 091393 ANDA091393 |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | American Health Packaging | aa7ac2bf-d9ed-445d-b394-4d3fe39780ca | 2025-10-17 | Boxed warning, Warnings, Adverse reactions | 091393 ANDA091393 68084-975 68084-354 68084-983 68084-968 |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | ST. MARY'S MEDICAL PARK PHARMACY | 3cd01fb7-b59c-fc5d-e063-6394a90a21d2 | 2025-08-20 | Boxed warning, Warnings, Adverse reactions | 091393 ANDA091393 |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | DIRECT RX | a8206207-ad09-83df-e053-2995a90a78b7 | 2025-06-05 | Boxed warning, Warnings, Adverse reactions | 091393 ANDA091393 72189-094 |
| Oxycodone HCL | OXYCODONE HCL | Direct_Rx | 31189587-a2dc-e0a1-e063-6394a90ae17d | 2025-03-24 | Boxed warning, Warnings, Adverse reactions | 091393 ANDA091393 |
| Oxycodone Hydchloride | OXYCODONE HYDCHLORIDE | Quality Care Products LLC | b9847cc7-67a2-408d-93cf-f9cf420346dd | 2024-12-19 | Warnings, Adverse reactions | 091393 ANDA091393 49999-899 |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Quality Care Products LLC | 4cadb809-157d-49cc-97b4-3276594f19d2 | 2024-12-19 | Warnings, Adverse reactions | 091393 ANDA091393 55700-175 55700-174 |
| Oxycodone Hydchloride | OXYCODONE HYDCHLORIDE | Quality Care Products LLC | 28156b13-0ba9-4dc4-be24-9c3070a7e1cc | 2024-12-16 | Warnings, Adverse reactions | 091393 ANDA091393 35356-839 |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 17f7946d-e889-b736-e063-6394a90a42e0 | 2024-05-08 | Boxed warning, Warnings, Adverse reactions | 091393 ANDA091393 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 10702-008 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | KVK-TECH,INC | ANDA | Current |
| 10702-009 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | KVK-TECH,INC | ANDA | Current |
| 10702-018 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | KVK-TECH,INC | ANDA | Current |
| 10702-056 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | KVK-TECH,INC | ANDA | Current |
| 10702-057 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | KVK-TECH,INC | ANDA | Current |
| 35356-839 | Oxycodone Hydchloride | Oxycodone Hydchloride | Lake Erie Medical DBA Qua | ANDA | Current |
| 35356-839 | Oxycodone Hydchloride | Oxycodone Hydchloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-839 | Oxycodone Hydchloride | Oxycodone Hydchloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-839 | Oxycodone Hydchloride | Oxycodone Hydchloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-839 | Oxycodone Hydchloride | Oxycodone Hydchloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 49999-899 | Oxycodone Hydchloride | Oxycodone Hydchloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 49999-899 | Oxycodone Hydchloride | Oxycodone Hydchloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 49999-899 | Oxycodone Hydchloride | Oxycodone Hydchloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-174 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-174 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-174 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-175 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-509 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-509 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Quality Care Products, LLC | ANDA | Current |
| 55700-509 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Quality Care Products, LLC | ANDA | Current |
| 55700-509 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 67296-0832 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | RedPharm Drug, Inc. | ANDA | Current |
| 67296-0832 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | RedPharm Drug, Inc. | ANDA | Current |
| 67296-0832 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | RedPharm Drug, Inc. | ANDA | Current |
| 68084-354 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | American Health Packaging | ANDA | Current |
| 68084-354 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | American Health Packaging | ANDA | Current |
| 68084-354 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | American Health Packaging | ANDA | Current |
| 68084-968 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | American Health Packaging | ANDA | Current |
| 68084-968 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | American Health Packaging | ANDA | Current |
| 68084-968 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | American Health Packaging | ANDA | Current |
| 68084-975 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | American Health Packaging | ANDA | Current |
| 68084-975 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | American Health Packaging | ANDA | Current |
| 68084-975 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | American Health Packaging | ANDA | Current |
| 68084-983 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | American Health Packaging | ANDA | Current |
| 68084-983 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | American Health Packaging | ANDA | Current |
| 68084-983 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | American Health Packaging | ANDA | Current |
| 71335-1245 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 72189-094 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 72189-094 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 72189-094 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | DIRECT RX | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76319 | ORIG | 2023-11-03 |