Application 207509
- 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 | 300MG;5MG | No | No |
| 002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 300MG;7.5MG | No | No |
| 003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 300MG;10MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A207509-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 300MG;5MG | TABLET / ORAL | AA | 2018-10-29 | |
| A207509-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 300MG;7.5MG | TABLET / ORAL | AA | 2018-10-29 | |
| A207509-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 300MG;10MG | TABLET / ORAL | AA | 2018-10-29 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A207509-001 | AA |
| A207509-002 | AA |
| A207509-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A207509-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | AA | 2018-10-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207509-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | AA | 2018-10-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207509-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | AA | 2018-10-29 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207509-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | AA | 2018-10-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207509-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | AA | 2018-10-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207509-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | AA | 2018-10-29 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207509-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | AA | 2018-10-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207509-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | AA | 2018-10-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207509-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | AA | 2018-10-29 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207509-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | AA | 2018-10-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207509-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | AA | 2018-10-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207509-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | AA | 2018-10-29 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207509-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | AA | 2018-10-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207509-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | AA | 2018-10-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207509-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | AA | 2018-10-29 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207509-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | AA | 2018-10-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207509-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | AA | 2018-10-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207509-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | AA | 2018-10-29 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207509-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | AA | 2018-10-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207509-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | AA | 2018-10-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207509-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | AA | 2018-10-29 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207509-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | AA | 2018-10-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207509-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | AA | 2018-10-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207509-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | AA | 2018-10-29 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207509-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | AA | 2018-10-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207509-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | AA | 2018-10-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207509-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | AA | 2018-10-29 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207509-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | AA | 2018-10-29 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207509-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | AA | 2018-10-29 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207509-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | AA | 2018-10-29 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207509-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | AA | 2018-10-29 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207509-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | AA | 2018-10-29 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207509-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | AA | 2018-10-29 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207509-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | AA | 2018-10-29 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207509-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | AA | 2018-10-29 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207509-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | AA | 2018-10-29 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207509-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | AA | 2018-10-29 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207509-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | AA | 2018-10-29 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207509-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | AA | 2018-10-29 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207509-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | AA | 2018-10-29 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A207509-001 | AA | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A207509-002 | AA | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A207509-003 | AA | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A207509-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207509-002 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207509-003 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207509-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207509-002 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207509-003 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A207509-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207509-002 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207509-003 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207509-001 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207509-002 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207509-003 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207509-001 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207509-002 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207509-003 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207509-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207509-002 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207509-003 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207509-001 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207509-002 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207509-003 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207509-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207509-002 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207509-003 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207509-001 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207509-002 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207509-003 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A207509-001 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A207509-002 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A207509-003 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207509-001 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207509-002 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207509-003 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207509-001 | AA | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207509-002 | AA | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207509-003 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207509-001 | AA | 1 | 1e350fbaab3a… |
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 | 1170f2f0-f087-4b68-afb5-7c049cb9a619 | 2026-03-23 | Boxed warning, Warnings, Adverse reactions | 207509 ANDA207509 |
| hydrocodone bitartrate and acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | afdc6256-f7d0-404b-a377-328250ab29ff | 2026-03-23 | Boxed warning, Warnings, Adverse reactions | 207509 ANDA207509 |
| hydrocodone bitartrate and acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 68c97e24-6898-4c17-813b-e1e62f56cb65 | 2026-03-23 | Boxed warning, Warnings, Adverse reactions | 207509 ANDA207509 |
| hydrocodone bitartrate and acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 2f6d0712-e756-49f2-a6b8-bbd160a454c4 | 2026-03-20 | Boxed warning, Warnings, Adverse reactions | 207509 ANDA207509 63629-1177 |
| hydrocodone bitartrate and acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | c648e299-2a8b-4530-a061-c6fd9cd1294c | 2026-03-20 | Boxed warning, Warnings, Adverse reactions | 207509 ANDA207509 63629-1181 63629-1184 63629-1179 |
| hydrocodone bitartrate and acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | f08ea7a7-211e-4e0b-88c3-8f29a567fdc0 | 2026-03-20 | Boxed warning, Warnings, Adverse reactions | 207509 ANDA207509 63629-1180 |
| hydrocodone bitartrate and acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 1cdeaf5e-5f82-4820-b244-b0ec7a7307e1 | 2026-03-20 | Boxed warning, Warnings, Adverse reactions | 207509 ANDA207509 63629-1183 |
| hydrocodone bitartrate and acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Eywa Pharma Inc | 8a201e19-3e47-7e58-e053-2995a90ab1d5 | 2026-03-06 | Boxed warning, Warnings, Adverse reactions | 207509 ANDA207509 71930-043 71930-042 71930-044 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 63629-1177 | hydrocodone bitartrate and acetaminophen | hydrocodone bitartrate and acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-1177 | hydrocodone bitartrate and acetaminophen | hydrocodone bitartrate and acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-1179 | hydrocodone bitartrate and acetaminophen | hydrocodone bitartrate and acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-1179 | hydrocodone bitartrate and acetaminophen | hydrocodone bitartrate and acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-1180 | hydrocodone bitartrate and acetaminophen | hydrocodone bitartrate and acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-1180 | hydrocodone bitartrate and acetaminophen | hydrocodone bitartrate and acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-1181 | hydrocodone bitartrate and acetaminophen | hydrocodone bitartrate and acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-1181 | hydrocodone bitartrate and acetaminophen | hydrocodone bitartrate and acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-1183 | hydrocodone bitartrate and acetaminophen | hydrocodone bitartrate and acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-1183 | hydrocodone bitartrate and acetaminophen | hydrocodone bitartrate and acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-1184 | hydrocodone bitartrate and acetaminophen | hydrocodone bitartrate and acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-1184 | hydrocodone bitartrate and acetaminophen | hydrocodone bitartrate and acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 71930-042 | hydrocodone bitartrate and acetaminophen | hydrocodone bitartrate and acetaminophen | Eywa Pharma Inc | ANDA | Current |
| 71930-042 | hydrocodone bitartrate and acetaminophen | hydrocodone bitartrate and acetaminophen | Eywa Pharma Inc | ANDA | Current |
| 71930-042 | hydrocodone bitartrate and acetaminophen | hydrocodone bitartrate and acetaminophen | Eywa Pharma Inc | ANDA | Current |
| 71930-043 | hydrocodone bitartrate and acetaminophen | hydrocodone bitartrate and acetaminophen | Eywa Pharma Inc | ANDA | Current |
| 71930-043 | hydrocodone bitartrate and acetaminophen | hydrocodone bitartrate and acetaminophen | Eywa Pharma Inc | ANDA | Current |
| 71930-043 | hydrocodone bitartrate and acetaminophen | hydrocodone bitartrate and acetaminophen | Eywa Pharma Inc | ANDA | Current |
| 71930-044 | hydrocodone bitartrate and acetaminophen | hydrocodone bitartrate and acetaminophen | Eywa Pharma Inc | ANDA | Current |
| 71930-044 | hydrocodone bitartrate and acetaminophen | hydrocodone bitartrate and acetaminophen | Eywa Pharma Inc | ANDA | Current |
| 71930-044 | hydrocodone bitartrate and acetaminophen | hydrocodone bitartrate and acetaminophen | Eywa Pharma Inc | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76425 | ORIG | 2023-11-07 |