Application 201972
- Type
- ANDA
- Sponsor
- AUROLIFE PHARMA LLC
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 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A201972-001 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;2.5MG | TABLET / ORAL | AA | 2013-07-15 | |
| A201972-002 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;5MG | TABLET / ORAL | AA | 2013-07-15 | |
| A201972-003 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;7.5MG | TABLET / ORAL | AA | 2013-07-15 | |
| A201972-004 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;10MG | TABLET / ORAL | AA | 2013-07-15 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A201972-001 | AA |
| A201972-002 | AA |
| A201972-003 | AA |
| A201972-004 | AA |
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 | A201972-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | AA | 2013-07-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A201972-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2013-07-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A201972-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2013-07-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A201972-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2013-07-15 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A201972-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | AA | 2013-07-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A201972-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2013-07-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A201972-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2013-07-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A201972-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2013-07-15 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201972-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | AA | 2013-07-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201972-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2013-07-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201972-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2013-07-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201972-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2013-07-15 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201972-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | AA | 2013-07-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201972-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2013-07-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201972-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2013-07-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201972-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2013-07-15 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201972-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | AA | 2013-07-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201972-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2013-07-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201972-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2013-07-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201972-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2013-07-15 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201972-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | AA | 2013-07-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201972-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2013-07-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201972-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2013-07-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201972-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2013-07-15 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201972-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | AA | 2013-07-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201972-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2013-07-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201972-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2013-07-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201972-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2013-07-15 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201972-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | AA | 2013-07-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201972-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2013-07-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201972-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2013-07-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201972-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2013-07-15 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201972-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | AA | 2013-07-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201972-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2013-07-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201972-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2013-07-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201972-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2013-07-15 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201972-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | AA | 2013-07-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201972-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2013-07-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201972-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2013-07-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201972-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2013-07-15 | d8e5a09893c0… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A201972-001 | AA | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A201972-002 | AA | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A201972-003 | AA | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A201972-004 | AA | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A201972-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A201972-002 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A201972-003 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A201972-004 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201972-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201972-002 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201972-003 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201972-004 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A201972-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A201972-002 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A201972-003 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A201972-004 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201972-001 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201972-002 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201972-003 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201972-004 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201972-001 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201972-002 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201972-003 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201972-004 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201972-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201972-002 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201972-003 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201972-004 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201972-001 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201972-002 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201972-003 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201972-004 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201972-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201972-002 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201972-003 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201972-004 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201972-001 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201972-002 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201972-003 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201972-004 | AA | 1 | d8e5a09893c0… |
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 | Aurolife Pharma, LLC | 69df20d9-b1d5-47dc-9ff0-29987284f8c7 | 2025-12-23 | Boxed warning, Warnings, Adverse reactions | 201972 ANDA201972 13107-044 13107-045 13107-043 13107-046 |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | Bryant Ranch Prepack | c12c26be-ba05-4d25-a2bf-f87623c6ae57 | 2024-08-09 | Boxed warning, Warnings, Adverse reactions | 201972 ANDA201972 71335-1036 |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | Proficient Rx LP | dd4dbe5b-8d07-4a96-a78d-2f20da761dad | 2019-11-01 | Boxed warning, Warnings, Adverse reactions | 201972 ANDA201972 63187-984 |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | Proficient Rx LP | df97ea5a-51df-453b-b1b4-edc74c718ee7 | 2019-10-01 | Boxed warning, Warnings, Adverse reactions | 201972 ANDA201972 63187-823 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 13107-043 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Aurolife Pharma LLC | ANDA | Current |
| 13107-043 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Aurolife Pharma LLC | ANDA | Current |
| 13107-043 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Aurolife Pharma, LLC | ANDA | Current |
| 13107-043 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Aurolife Pharma, LLC | ANDA | Current |
| 13107-044 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Aurolife Pharma LLC | ANDA | Current |
| 13107-044 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Aurolife Pharma LLC | ANDA | Current |
| 13107-044 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Aurolife Pharma, LLC | ANDA | Current |
| 13107-044 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Aurolife Pharma, LLC | ANDA | Current |
| 13107-045 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Aurolife Pharma LLC | ANDA | Current |
| 13107-045 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Aurolife Pharma LLC | ANDA | Current |
| 13107-045 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Aurolife Pharma, LLC | ANDA | Current |
| 13107-045 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Aurolife Pharma, LLC | ANDA | Current |
| 13107-046 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Aurolife Pharma LLC | ANDA | Current |
| 13107-046 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Aurolife Pharma LLC | ANDA | Current |
| 13107-046 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Aurolife Pharma, LLC | ANDA | Current |
| 13107-046 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Aurolife Pharma, LLC | ANDA | Current |
| 55700-496 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-496 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-496 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-496 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-496 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-496 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-496 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-496 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-496 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Lake Erie Medical DBA Qua | ANDA | Current |
| 55700-496 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-496 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Quality Care Products LLC | ANDA | Current |
| 55700-496 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-496 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-496 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-496 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-496 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-497 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-497 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-497 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-497 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-497 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-497 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-497 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-497 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-497 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Lake Erie Medical DBA Qua | ANDA | Current |
| 55700-497 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-497 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Quality Care Products LLC | ANDA | Current |
| 55700-497 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-497 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-497 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-497 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-497 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-498 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-498 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-498 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-498 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-498 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-498 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-498 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-498 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-498 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Lake Erie Medical DBA Qua | ANDA | Current |
| 55700-498 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-498 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Quality Care Products LLC | ANDA | Current |
| 55700-498 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-498 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-498 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-498 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-498 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 60760-274 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-276 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 61919-412 | OXYCODONE APAP | OXYCODONE APAP | DIRECT RX | ANDA | Current |
| 61919-412 | OXYCODONE APAP | OXYCODONE APAP | DIRECT RX | ANDA | Current |
| 61919-437 | OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHE | DIRECT RX | ANDA | Current |
| 61919-437 | OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHE | DIRECT RX | ANDA | Current |
| 61919-524 | OXYCODONE/APAP | OXYCODONE/APAP | DirectRX | ANDA | Current |
| 63187-823 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Proficient Rx LP | ANDA | Current |
| 63187-823 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Proficient Rx LP | ANDA | Current |
| 63187-984 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Proficient Rx LP | ANDA | Current |
| 63187-984 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Proficient Rx LP | ANDA | Current |
| 67296-1392 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1392 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1392 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1392 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | RedPharm Drug, Inc. | ANDA | Current |
| 71335-1036 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76326 | ORIG | 2023-11-03 |