Application 210211
- Type
- ANDA
- Sponsor
- WES PHARMA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 325MG;5MG | No | No |
| 002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 325MG;7.5MG | No | No |
| 003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 325MG;10MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A210211-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;5MG | TABLET / ORAL | AA | 2017-10-30 | |
| A210211-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;7.5MG | TABLET / ORAL | AA | 2017-10-30 | |
| A210211-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;10MG | TABLET / ORAL | AA | 2017-10-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A210211-001 | AA |
| A210211-002 | AA |
| A210211-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A210211-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-10-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210211-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2017-10-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210211-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2017-10-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210211-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-10-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210211-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2017-10-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210211-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2017-10-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210211-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-10-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210211-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2017-10-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210211-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2017-10-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210211-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-10-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210211-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2017-10-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210211-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2017-10-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210211-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-10-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210211-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2017-10-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210211-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2017-10-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210211-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-10-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210211-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2017-10-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210211-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2017-10-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210211-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-10-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210211-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2017-10-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210211-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2017-10-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210211-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-10-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210211-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2017-10-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210211-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2017-10-30 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210211-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-10-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210211-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2017-10-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210211-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2017-10-30 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210211-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-10-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210211-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2017-10-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210211-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2017-10-30 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210211-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-10-30 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210211-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2017-10-30 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210211-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2017-10-30 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210211-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-10-30 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210211-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2017-10-30 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210211-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2017-10-30 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210211-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-10-30 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210211-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2017-10-30 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210211-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2017-10-30 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A210211-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-10-30 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A210211-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210211-002 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210211-003 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210211-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210211-002 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210211-003 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A210211-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210211-002 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210211-003 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210211-001 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210211-002 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210211-003 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210211-001 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210211-002 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210211-003 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210211-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210211-002 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210211-003 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210211-001 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210211-002 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210211-003 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210211-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210211-002 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210211-003 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210211-001 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210211-002 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210211-003 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A210211-001 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A210211-002 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A210211-003 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210211-001 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210211-002 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210211-003 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210211-001 | AA | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210211-002 | AA | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210211-003 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210211-001 | AA | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210211-002 | AA | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210211-003 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A210211-001 | AA | 1 | 8072bd15b7f6… |
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 |
|---|---|---|---|---|---|---|
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 65c5abc7-520a-4267-acb6-ea6204a3ecfa | 2026-05-29 | Boxed warning, Warnings, Adverse reactions | 210211 ANDA210211 71335-2116 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 080d8fbd-a2c5-45b1-a9cf-2b6dd42ec4c7 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | 210211 ANDA210211 71335-1970 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 69ce724d-6440-4def-aea9-26ad284ac35c | 2026-04-22 | Boxed warning, Warnings, Adverse reactions | 210211 ANDA210211 63629-8885 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | f1a7d87c-866d-4c6d-b9fd-e809b0a21773 | 2026-03-25 | Boxed warning, Warnings, Adverse reactions | 210211 ANDA210211 63629-1940 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 1d63d261-bdd4-4951-b8aa-09561e5b19fc | 2026-03-25 | Boxed warning, Warnings, Adverse reactions | 210211 ANDA210211 63629-1939 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 09db348f-8396-41b2-b639-608dcfdbccf4 | 2026-03-25 | Boxed warning, Warnings, Adverse reactions | 210211 ANDA210211 63629-1938 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | db14e63a-8e3e-4524-b45a-cb09f705f73a | 2026-03-23 | Boxed warning, Warnings, Adverse reactions | 210211 ANDA210211 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | e5b559c3-4beb-4ba3-a10b-7a1ad1878a1e | 2026-03-23 | Boxed warning, Warnings, Adverse reactions | 210211 ANDA210211 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | c534f784-0e21-4891-8f7e-2dc327b267f1 | 2026-03-23 | Boxed warning, Warnings, Adverse reactions | 210211 ANDA210211 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Asclemed USA, Inc. | 66e184cd-fa32-431f-b843-9c4bea12593b | 2026-03-10 | Boxed warning, Warnings, Adverse reactions | 210211 ANDA210211 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Redpharm Drug | 46c13d54-b181-4da2-e063-6294a90ab5c5 | 2026-03-03 | Boxed warning, Warnings, Adverse reactions | 210211 ANDA210211 |
| Hydrocodone/APAP | HYDROCODONE/APAP | Direct_Rx | 446e9f78-4034-5bb4-e063-6394a90ac739 | 2026-02-05 | Boxed warning, Warnings, Adverse reactions | 210211 ANDA210211 |
| Hydrocodone/APAP | HYDROCODONE/APAP | Direct_Rx | 446f01f0-2853-d104-e063-6394a90ae351 | 2026-02-05 | Boxed warning, Warnings, Adverse reactions | 210211 ANDA210211 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Eywa Pharma Inc | fcd2b59e-8087-475e-9e6b-911bd846ea96 | 2025-10-03 | Boxed warning, Warnings, Adverse reactions | 210211 ANDA210211 71930-020 71930-019 71930-021 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | NuCare Pharmaceuticals,Inc. | fed1eb12-3e39-1bf9-e053-6294a90afd77 | 2025-02-05 | Boxed warning, Warnings, Adverse reactions | 210211 ANDA210211 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | American Health Packaging | 9d76aaf6-e3e0-4ec1-9f20-3d5ab88de630 | 2025-01-10 | Boxed warning, Warnings, Adverse reactions | 210211 ANDA210211 60687-396 60687-418 60687-407 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | NuCare Pharmaceuticals,Inc. | d88e04c1-cd54-6a12-e053-2995a90a22b4 | 2024-12-24 | Boxed warning, Warnings, Adverse reactions | 210211 ANDA210211 68071-2645 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 2a485efe-a87c-4c55-9e17-7891b2fffb83 | 2024-09-06 | Boxed warning, Warnings, Adverse reactions | 210211 ANDA210211 71335-2144 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 42a74abc-bdc7-4ea3-a185-029340111730 | 2024-09-05 | Boxed warning, Warnings, Adverse reactions | 210211 ANDA210211 63629-8886 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | NuCare Pharmaceuticals,Inc. | c8d65aab-d6ae-bc69-e053-2a95a90a7b5e | 2024-03-27 | Boxed warning, Warnings, Adverse reactions | 210211 ANDA210211 68071-2494 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 60687-396 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | American Health Packaging | ANDA | Current |
| 60687-396 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | American Health Packaging | ANDA | Current |
| 60687-396 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | American Health Packaging | ANDA | Current |
| 60687-407 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | American Health Packaging | ANDA | Current |
| 60687-407 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | American Health Packaging | ANDA | Current |
| 60687-407 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | American Health Packaging | ANDA | Current |
| 60687-407 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | American Health Packaging | ANDA | Current |
| 60687-418 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | American Health Packaging | ANDA | Current |
| 60687-418 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | American Health Packaging | ANDA | Current |
| 60687-418 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | American Health Packaging | ANDA | Current |
| 60687-418 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | American Health Packaging | ANDA | Current |
| 63629-1938 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-1938 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-1938 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-1939 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-1939 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-1939 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-1940 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-1940 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-1940 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-8885 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-8886 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-8887 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 68071-2494 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2629 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2645 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2664 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2664 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2762 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 71335-1970 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 71335-2116 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 71335-2144 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 71930-019 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Eywa Pharma Inc | ANDA | Current |
| 71930-019 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Eywa Pharma Inc | ANDA | Current |
| 71930-019 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Eywa Pharma Inc | ANDA | Current |
| 71930-019 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Eywa Pharma Inc | ANDA | Current |
| 71930-019 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Eywa Pharma Inc | ANDA | Current |
| 71930-019 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Eywa Pharma Inc | ANDA | Current |
| 71930-020 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Eywa Pharma Inc | ANDA | Current |
| 71930-020 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Eywa Pharma Inc | ANDA | Current |
| 71930-020 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Eywa Pharma Inc | ANDA | Current |
| 71930-020 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Eywa Pharma Inc | ANDA | Current |
| 71930-020 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Eywa Pharma Inc | ANDA | Current |
| 71930-020 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Eywa Pharma Inc | ANDA | Current |
| 71930-021 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Eywa Pharma Inc | ANDA | Current |
| 71930-021 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Eywa Pharma Inc | ANDA | Current |
| 71930-021 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Eywa Pharma Inc | ANDA | Current |
| 71930-021 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Eywa Pharma Inc | ANDA | Current |
| 71930-021 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Eywa Pharma Inc | ANDA | Current |
| 71930-021 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Eywa Pharma Inc | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76204 | ORIG | 2023-11-03 |