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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 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… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202214-005 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | AA | 2016-03-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202214-006 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | AA | 2016-03-15 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202214-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2013-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202214-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2013-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202214-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2013-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202214-004 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | AA | 2016-03-15 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 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… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202214-005 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202214-006 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202214-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202214-002 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202214-003 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202214-004 | AA | 1 | 03ed91905a0d… |
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 | St. Mary's Medical Park Pharmacy | 425258b6-72d7-e9b5-e063-6394a90a3fc7 | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | 202214 ANDA202214 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | St. Mary's Medical Park Pharmacy | 4135fb50-2e77-7365-e063-6294a90a8c43 | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | 202214 ANDA202214 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 375c3f81-3276-431e-8773-7b189730e9fd | 2026-05-20 | Boxed warning, Warnings, Adverse reactions | 202214 ANDA202214 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ST. MARY'S MEDICAL PARK PHARMACY | 3d347b9b-1b5c-68c8-e063-6294a90aaa9b | 2026-05-19 | Boxed warning, Warnings, Adverse reactions | 202214 ANDA202214 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 8e99994a-83b4-4b1f-9654-4ae373bf2c4d | 2026-04-09 | Boxed warning, Warnings, Adverse reactions | 202214 ANDA202214 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 5a7fb0e7-eb06-4332-a786-d0051afd1dd9 | 2026-04-09 | Boxed warning, Warnings, Adverse reactions | 202214 ANDA202214 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 679b4f87-59df-48d4-a9e6-e78aaeab23ea | 2026-04-09 | Boxed warning, Warnings, Adverse reactions | 202214 ANDA202214 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | d3b7f2b3-28c4-4ba5-961f-48e838600be2 | 2026-04-09 | Boxed warning, Warnings, Adverse reactions | 202214 ANDA202214 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 092f4694-98df-41bd-b37c-afbcda087e56 | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | 202214 ANDA202214 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | a3cbf0c1-b589-4e4a-b355-01bddb7e4955 | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | 202214 ANDA202214 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | f7b554ab-2996-4cf0-a498-01cd5ef5df4f | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | 202214 ANDA202214 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 5431c1bf-469b-4944-a558-52d098c9b0f0 | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | 202214 ANDA202214 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | e5d6de20-c195-4b97-963a-2f3832e50b49 | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | 202214 ANDA202214 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 6fae7c90-1d80-4eb8-bbb8-8f945884f5c6 | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | 202214 ANDA202214 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 806a981f-85ff-4e58-8ff0-7ab02ed2e5c1 | 2026-03-10 | Boxed warning, Warnings, Adverse reactions | 202214 ANDA202214 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Cranbury Pharmaceuticals, LLC | d8fe4ae4-bd19-42eb-b74d-f302b3f914ee | 2025-12-23 | Boxed warning, Warnings, Adverse reactions | 202214 ANDA202214 27808-115 27808-116 27808-114 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Cranbury Pharmaceuticals, LLC | d4caec6d-4af2-4f1c-9add-c0c948b83b16 | 2025-12-23 | Boxed warning, Warnings, Adverse reactions | 202214 ANDA202214 27808-036 27808-037 27808-035 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 36bf5e37-9202-4288-8354-9d123fb692d3 | 2025-10-23 | Boxed warning, Warnings, Adverse reactions | 202214 ANDA202214 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | fa88d7b2-6c8e-4893-bd81-ecd4f2aca493 | 2025-07-29 | Boxed warning, Warnings, Adverse reactions | 202214 ANDA202214 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Asclemed USA, Inc. | ba7d27eb-952d-4e99-95b9-5b0b2f85794b | 2025-04-24 | Boxed warning, Warnings, Adverse reactions | 202214 ANDA202214 |
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 |