Application 202214
- Type
- ANDA
- Sponsor
- TRIS 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 |
| 004 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 300MG;5MG | No | No |
| 005 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 300MG;7.5MG | No | No |
| 006 | 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 |
|---|---|---|---|---|---|---|---|
| A202214-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;5MG | TABLET / ORAL | AA | 2013-03-27 | |
| A202214-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;7.5MG | TABLET / ORAL | AA | 2013-03-27 | |
| A202214-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;10MG | TABLET / ORAL | AA | 2013-03-27 | |
| A202214-004 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 300MG;5MG | TABLET / ORAL | AA | 2016-03-15 | |
| A202214-005 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 300MG;7.5MG | TABLET / ORAL | AA | 2016-03-15 | |
| A202214-006 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 300MG;10MG | TABLET / ORAL | AA | 2016-03-15 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A202214-001 | AA |
| A202214-002 | AA |
| A202214-003 | AA |
| A202214-004 | AA |
| A202214-005 | AA |
| A202214-006 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A202214-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2013-03-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A202214-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2013-03-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A202214-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2013-03-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A202214-004 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | AA | 2016-03-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A202214-005 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | AA | 2016-03-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A202214-006 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | AA | 2016-03-15 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A202214-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2013-03-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202214-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2013-03-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202214-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2013-03-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202214-004 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | AA | 2016-03-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202214-005 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | AA | 2016-03-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202214-006 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | AA | 2016-03-15 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202214-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2013-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202214-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2013-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202214-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2013-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202214-004 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | AA | 2016-03-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202214-005 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | AA | 2016-03-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202214-006 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | AA | 2016-03-15 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202214-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2013-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202214-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2013-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202214-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2013-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202214-004 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | AA | 2016-03-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202214-005 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | AA | 2016-03-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202214-006 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | AA | 2016-03-15 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202214-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2013-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202214-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2013-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202214-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2013-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202214-004 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | AA | 2016-03-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202214-005 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | AA | 2016-03-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202214-006 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | AA | 2016-03-15 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202214-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2013-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202214-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2013-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202214-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2013-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202214-004 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | AA | 2016-03-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202214-005 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | AA | 2016-03-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202214-006 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | AA | 2016-03-15 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202214-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2013-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202214-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2013-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202214-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2013-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202214-004 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | AA | 2016-03-15 | b8a1b40f171c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A202214-001 | AA | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A202214-002 | AA | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A202214-003 | AA | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A202214-004 | AA | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A202214-005 | AA | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A202214-006 | AA | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A202214-001 | AA | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202214-002 | AA | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202214-003 | AA | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202214-004 | AA | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202214-005 | AA | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202214-006 | AA | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A202214-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202214-002 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202214-003 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202214-004 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202214-005 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202214-006 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202214-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202214-002 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202214-003 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202214-004 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202214-005 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202214-006 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202214-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202214-002 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202214-003 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202214-004 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202214-005 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202214-006 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202214-001 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202214-002 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202214-003 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202214-004 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202214-005 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202214-006 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202214-001 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202214-002 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202214-003 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202214-004 | AA | 1 | b8a1b40f171c… |
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 | ab3646f2-1f09-4dec-9b4b-535ee9c0d3fe | 2025-03-21 | Boxed warning, Warnings, Adverse reactions | 202214 ANDA202214 63629-2309 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | ddb58213-79b7-466b-bac4-01fd2d410cba | 2025-03-21 | Boxed warning, Warnings, Adverse reactions | 202214 ANDA202214 63629-2308 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 3aa038f9-f837-466f-aa3c-68a7bd0b2388 | 2025-03-21 | Boxed warning, Warnings, Adverse reactions | 202214 ANDA202214 63629-2310 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | a5f2b04d-d1ed-4070-9239-2fd3c36994cb | 2025-03-20 | Boxed warning, Warnings, Adverse reactions | 202214 ANDA202214 63629-2297 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | c9f7f4c1-c4e2-4f9b-bb02-72fb35eb4325 | 2025-03-20 | Boxed warning, Warnings, Adverse reactions | 202214 ANDA202214 63629-2293 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | b1e520d2-0347-4399-a765-fcacbc50f288 | 2025-03-20 | Boxed warning, Warnings, Adverse reactions | 202214 ANDA202214 63629-2299 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | de918a56-c43e-44c7-941c-f9dd581845a7 | 2025-03-20 | Boxed warning, Warnings, Adverse reactions | 202214 ANDA202214 63629-2294 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 58f5603e-01c9-44f8-b947-3918fd14e049 | 2025-03-20 | Boxed warning, Warnings, Adverse reactions | 202214 ANDA202214 63629-2296 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 2ad2d00e-3796-4605-852f-a3d64d5ef09f | 2024-10-04 | Boxed warning, Warnings, Adverse reactions | 202214 ANDA202214 63629-2292 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | NuCare Pharmaceuticals, Inc. | 226765e9-a6b1-22b6-e063-6394a90a364e | 2024-09-18 | Boxed warning, Warnings, Adverse reactions | 202214 ANDA202214 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 9698729e-08d0-483c-b157-5a4061d97065 | 2024-08-19 | Boxed warning, Warnings, Adverse reactions | 202214 ANDA202214 63629-2300 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 6dde2f85-e329-4bca-832d-d45786df9f52 | 2024-08-19 | Boxed warning, Warnings, Adverse reactions | 202214 ANDA202214 63629-2298 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 6ad80616-b38d-4569-b24a-aa86e39feb66 | 2024-08-12 | Boxed warning, Warnings, Adverse reactions | 202214 ANDA202214 63629-2295 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 27808-035 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Tris Pharma Inc | ANDA | Current |
| 27808-035 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Tris Pharma Inc | ANDA | Current |
| 27808-035 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Tris Pharma Inc | ANDA | Current |
| 27808-035 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Tris Pharma Inc | ANDA | Current |
| 27808-035 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Tris Pharma Inc | ANDA | Current |
| 27808-035 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Tris Pharma Inc | ANDA | Current |
| 27808-036 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Tris Pharma Inc | ANDA | Current |
| 27808-036 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Tris Pharma Inc | ANDA | Current |
| 27808-036 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Tris Pharma Inc | ANDA | Current |
| 27808-036 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Tris Pharma Inc | ANDA | Current |
| 27808-036 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Tris Pharma Inc | ANDA | Current |
| 27808-036 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Tris Pharma Inc | ANDA | Current |
| 27808-037 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Tris Pharma Inc | ANDA | Current |
| 27808-037 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Tris Pharma Inc | ANDA | Current |
| 27808-037 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Tris Pharma Inc | ANDA | Current |
| 27808-037 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Tris Pharma Inc | ANDA | Current |
| 27808-037 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Tris Pharma Inc | ANDA | Current |
| 27808-037 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Tris Pharma Inc | ANDA | Current |
| 27808-114 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Tris Pharma Inc | ANDA | Current |
| 27808-114 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Tris Pharma Inc | ANDA | Current |
| 27808-114 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Tris Pharma Inc | ANDA | Current |
| 27808-114 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Tris Pharma Inc | ANDA | Current |
| 27808-114 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Tris Pharma Inc | ANDA | Current |
| 27808-114 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Tris Pharma Inc | ANDA | Current |
| 27808-114 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Tris Pharma Inc | ANDA | Current |
| 27808-115 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Tris Pharma Inc | ANDA | Current |
| 27808-115 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Tris Pharma Inc | ANDA | Current |
| 27808-115 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Tris Pharma Inc | ANDA | Current |
| 27808-115 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Tris Pharma Inc | ANDA | Current |
| 27808-115 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Tris Pharma Inc | ANDA | Current |
| 27808-115 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Tris Pharma Inc | ANDA | Current |
| 27808-115 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Tris Pharma Inc | ANDA | Current |
| 27808-116 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Tris Pharma Inc | ANDA | Current |
| 27808-116 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Tris Pharma Inc | ANDA | Current |
| 27808-116 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Tris Pharma Inc | ANDA | Current |
| 27808-116 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Tris Pharma Inc | ANDA | Current |
| 27808-116 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Tris Pharma Inc | ANDA | Current |
| 27808-116 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Tris Pharma Inc | ANDA | Current |
| 27808-116 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Tris Pharma Inc | ANDA | Current |
| 63629-2292 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-2292 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-2292 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-2293 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-2293 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-2293 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-2294 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-2294 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-2294 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-2295 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-2295 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-2295 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-2296 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-2296 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-2296 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-2297 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-2297 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-2297 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-2298 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-2298 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-2298 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-2299 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-2299 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-2299 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-2300 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-2300 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-2300 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-2308 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-2308 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-2308 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-2309 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-2309 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-2309 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-2310 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-2310 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-2310 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 67296-1571 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1571 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1571 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1574 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1574 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | RedPharm Drug, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76147 | ORIG | 2023-11-03 |