Application 208540
- Type
- ANDA
- Sponsor
- ALVOGEN PINE BROOK
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 |
|---|---|---|---|---|---|---|---|
| A208540-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 300MG;5MG | TABLET / ORAL | 2018-11-08 | ||
| A208540-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 300MG;7.5MG | TABLET / ORAL | 2018-11-08 | ||
| A208540-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 300MG;10MG | TABLET / ORAL | 2018-11-08 |
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 | A208540-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | 2018-11-08 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A208540-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | 2018-11-08 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A208540-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | 2018-11-08 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208540-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | 2018-11-08 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208540-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | 2018-11-08 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208540-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | 2018-11-08 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A208540-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | 2018-11-08 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A208540-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | 2018-11-08 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A208540-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | 2018-11-08 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208540-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | 2018-11-08 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208540-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | 2018-11-08 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208540-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | 2018-11-08 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208540-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | 2018-11-08 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208540-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | 2018-11-08 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208540-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | 2018-11-08 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208540-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | 2018-11-08 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208540-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | 2018-11-08 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208540-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | 2018-11-08 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208540-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | 2018-11-08 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208540-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | 2018-11-08 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208540-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | 2018-11-08 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208540-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | 2018-11-08 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208540-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | 2018-11-08 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208540-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | 2018-11-08 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208540-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | 2018-11-08 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208540-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | 2018-11-08 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208540-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | 2018-11-08 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A208540-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | 2018-11-08 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A208540-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | 2018-11-08 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A208540-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | 2018-11-08 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208540-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | 2018-11-08 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208540-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | 2018-11-08 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208540-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | 2018-11-08 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A208540-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | 2018-11-08 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A208540-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | 2018-11-08 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A208540-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | 2018-11-08 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A208540-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | 2018-11-08 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A208540-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | 2018-11-08 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A208540-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | 2018-11-08 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A208540-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | 2018-11-08 | 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 | Eywa Pharma Inc | adb37532-aa19-48a2-95a1-8c92a6ce8651 | 2026-07-18 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| hydrocodone bitartrate and acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Proficient Rx LP | d36f86e2-fe0f-4b74-a5bf-b23082d72da2 | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | hydrocodone bitartrate and acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 8ad0df84-e3f6-4c1d-b791-c8467eb984aa | 2026-06-18 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | St. Mary's Medical Park Pharmacy | 3d3292f0-93b5-1fd0-e063-6294a90a3716 | 2026-06-15 | Boxed warning, Warnings, Adverse reactions | HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | ddfe71cc-27bf-4807-b62f-e6cf982e2dfd | 2026-06-11 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| 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 | Hydrocodone Bitartrate and Acetaminophen |
| 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 | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 418ea599-55e0-4d57-a4b1-16568e30f6f7 | 2026-06-08 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 25d49886-9f9a-4015-bca2-9190b30d9120 | 2026-06-08 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | e83d90f9-513b-47c2-ae2a-748ce775ef5d | 2026-06-05 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 380ff458-d5d7-422e-ac96-e9a56ade16b6 | 2026-06-01 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Rhodes Pharmaceuticals LLC | 1f9c1adc-f84f-43de-af5c-d93703aba7f8 | 2026-05-29 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 65c5abc7-520a-4267-acb6-ea6204a3ecfa | 2026-05-29 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 44687e20-a1c4-4cf3-b2ac-4d489d54b740 | 2026-05-27 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 3d431951-eb0f-45ac-a6ba-d99929bdcaaf | 2026-05-27 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 878c004c-1e92-4400-95f5-e79cf9ba6844 | 2026-05-27 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 080d8fbd-a2c5-45b1-a9cf-2b6dd42ec4c7 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ST. MARY'S MEDICAL PARK PHARMACY | 3d342071-7fdd-d899-e063-6294a90ae782 | 2026-05-20 | Boxed warning, Warnings, Adverse reactions | HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 375c3f81-3276-431e-8773-7b189730e9fd | 2026-05-20 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| 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 | Hydrocodone Bitartrate and Acetaminophen |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 47781-444 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Alvogen Inc. | ANDA | Current |
| 47781-445 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Alvogen Inc. | ANDA | Current |
| 47781-446 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Alvogen Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76427 | ORIG | 2023-11-07 |