Application 074199
- Type
- ANDA
- Sponsor
- ROXANE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ALPRAZOLAM | ALPRAZOLAM | TABLET;ORAL | 0.25MG | No | No |
| 002 | ALPRAZOLAM | ALPRAZOLAM | TABLET;ORAL | 0.5MG | No | No |
| 003 | ALPRAZOLAM | ALPRAZOLAM | TABLET;ORAL | 1MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A074199-001 | ALPRAZOLAM | ALPRAZOLAM | 0.25MG | TABLET / ORAL | 1993-10-19 | ||
| A074199-002 | ALPRAZOLAM | ALPRAZOLAM | 0.5MG | TABLET / ORAL | 1993-10-19 | ||
| A074199-003 | ALPRAZOLAM | ALPRAZOLAM | 1MG | TABLET / ORAL | 1993-10-19 |
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 | A074199-001 | ALPRAZOLAM | 0.25MG | TABLET / ORAL | 1993-10-19 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A074199-002 | ALPRAZOLAM | 0.5MG | TABLET / ORAL | 1993-10-19 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A074199-003 | ALPRAZOLAM | 1MG | TABLET / ORAL | 1993-10-19 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A074199-001 | ALPRAZOLAM | 0.25MG | TABLET / ORAL | 1993-10-19 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A074199-002 | ALPRAZOLAM | 0.5MG | TABLET / ORAL | 1993-10-19 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A074199-003 | ALPRAZOLAM | 1MG | TABLET / ORAL | 1993-10-19 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A074199-001 | ALPRAZOLAM | 0.25MG | TABLET / ORAL | 1993-10-19 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A074199-002 | ALPRAZOLAM | 0.5MG | TABLET / ORAL | 1993-10-19 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A074199-003 | ALPRAZOLAM | 1MG | TABLET / ORAL | 1993-10-19 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074199-001 | ALPRAZOLAM | 0.25MG | TABLET / ORAL | 1993-10-19 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074199-002 | ALPRAZOLAM | 0.5MG | TABLET / ORAL | 1993-10-19 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074199-003 | ALPRAZOLAM | 1MG | TABLET / ORAL | 1993-10-19 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A074199-001 | ALPRAZOLAM | 0.25MG | TABLET / ORAL | 1993-10-19 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A074199-002 | ALPRAZOLAM | 0.5MG | TABLET / ORAL | 1993-10-19 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A074199-003 | ALPRAZOLAM | 1MG | TABLET / ORAL | 1993-10-19 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074199-001 | ALPRAZOLAM | 0.25MG | TABLET / ORAL | 1993-10-19 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074199-002 | ALPRAZOLAM | 0.5MG | TABLET / ORAL | 1993-10-19 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074199-003 | ALPRAZOLAM | 1MG | TABLET / ORAL | 1993-10-19 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074199-001 | ALPRAZOLAM | 0.25MG | TABLET / ORAL | 1993-10-19 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074199-002 | ALPRAZOLAM | 0.5MG | TABLET / ORAL | 1993-10-19 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074199-003 | ALPRAZOLAM | 1MG | TABLET / ORAL | 1993-10-19 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074199-001 | ALPRAZOLAM | 0.25MG | TABLET / ORAL | 1993-10-19 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074199-002 | ALPRAZOLAM | 0.5MG | TABLET / ORAL | 1993-10-19 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074199-003 | ALPRAZOLAM | 1MG | TABLET / ORAL | 1993-10-19 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074199-001 | ALPRAZOLAM | 0.25MG | TABLET / ORAL | 1993-10-19 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074199-002 | ALPRAZOLAM | 0.5MG | TABLET / ORAL | 1993-10-19 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074199-003 | ALPRAZOLAM | 1MG | TABLET / ORAL | 1993-10-19 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074199-001 | ALPRAZOLAM | 0.25MG | TABLET / ORAL | 1993-10-19 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074199-002 | ALPRAZOLAM | 0.5MG | TABLET / ORAL | 1993-10-19 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074199-003 | ALPRAZOLAM | 1MG | TABLET / ORAL | 1993-10-19 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074199-001 | ALPRAZOLAM | 0.25MG | TABLET / ORAL | 1993-10-19 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074199-002 | ALPRAZOLAM | 0.5MG | TABLET / ORAL | 1993-10-19 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074199-003 | ALPRAZOLAM | 1MG | TABLET / ORAL | 1993-10-19 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A074199-001 | ALPRAZOLAM | 0.25MG | TABLET / ORAL | 1993-10-19 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A074199-002 | ALPRAZOLAM | 0.5MG | TABLET / ORAL | 1993-10-19 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A074199-003 | ALPRAZOLAM | 1MG | TABLET / ORAL | 1993-10-19 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074199-001 | ALPRAZOLAM | 0.25MG | TABLET / ORAL | 1993-10-19 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074199-002 | ALPRAZOLAM | 0.5MG | TABLET / ORAL | 1993-10-19 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074199-003 | ALPRAZOLAM | 1MG | TABLET / ORAL | 1993-10-19 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074199-001 | ALPRAZOLAM | 0.25MG | TABLET / ORAL | 1993-10-19 | 301d65b070ca… |
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 |
|---|---|---|---|---|---|---|
| Alprazolam Extended Release | ALPRAZOLAM | Bryant Ranch Prepack | 4f6e4656-689f-46a6-a8ed-54ee55583357 | 2023-05-08 | Boxed warning, Warnings, Adverse reactions | ALPRAZOLAM |
| Xanax XR | ALPRAZOLAM | Viatris Specialty LLC | c8990714-c2f5-4b0c-9f1c-91d77156d962 | 2023-04-12 | Boxed warning, Warnings, Adverse reactions | ALPRAZOLAM |
| Alprazolam | ALPRAZOLAM | Aphena Pharma Solutions - Tennessee, LLC | 54c790c5-2e6c-439d-8e3b-7502c962a596 | 2023-03-20 | Boxed warning, Warnings, Adverse reactions | Alprazolam ALPRAZOLAM |
| Alprazolam | ALPRAZOLAM | Hikma Pharmaceuticals USA Inc. | b945ac6f-796e-41ef-85e9-61007e4a4e9a | 2023-01-18 | Boxed warning, Warnings, Adverse reactions | Alprazolam ALPRAZOLAM |
| Xanax | ALPRAZOLAM | PHARMACIA & UPJOHN COMPANY LLC | 388e249d-b9b6-44c3-9f8f-880eced0239f | 2023-01-18 | Boxed warning, Warnings, Adverse reactions | ALPRAZOLAM |
| Alprazolam | ALPRAZOLAM | Actavis Pharma, Inc. | a23063c0-099a-4256-b95f-3a857bbf704b | 2023-01-01 | Boxed warning, Warnings, Adverse reactions | Alprazolam ALPRAZOLAM |
| Alprazolam | ALPRAZOLAM | Actavis Pharma, Inc. | 5ceed721-2e65-4c81-bd84-f110b1ac9d2e | 2022-12-01 | Boxed warning, Warnings, Adverse reactions | Alprazolam ALPRAZOLAM |
| Alprazolam | ALPRAZOLAM | Proficient Rx LP | 4579facb-b225-4108-a5ef-dada926ef7cf | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | Alprazolam ALPRAZOLAM |
| Alprazolam | ALPRAZOLAM | Proficient Rx LP | 34631dbf-f817-484d-8bcf-f8efa07178d7 | 2021-01-01 | Warnings, Adverse reactions | Alprazolam ALPRAZOLAM |
| Alprazolam | ALPRAZOLAM | Proficient Rx LP | 969acb29-3b5c-47ed-8f7d-a960a24e72e3 | 2021-01-01 | Warnings, Adverse reactions | Alprazolam ALPRAZOLAM |
| Alprazolam | ALPRAZOLAM | Proficient Rx LP | 717ce509-f92e-4ec1-a3c6-aeae54d56f4d | 2020-08-01 | Warnings, Adverse reactions | Alprazolam ALPRAZOLAM |
| Alprazolam | ALPRAZOLAM | Proficient Rx LP | 447efe78-3696-481c-bbae-23199a39ec94 | 2019-11-01 | Warnings, Adverse reactions | Alprazolam ALPRAZOLAM |
| Alprazolam | ALPRAZOLAM | Proficient Rx LP | f6990b57-7011-4cdf-8abc-1794e2e0c7f1 | 2019-11-01 | Boxed warning, Warnings, Adverse reactions | Alprazolam ALPRAZOLAM |
| Alprazolam | ALPRAZOLAM | Aphena Pharma Solutions - Tennessee, LLC | 29ddd9f2-c116-467b-8db3-38166482aea0 | 2018-08-23 | Boxed warning, Warnings, Adverse reactions | Alprazolam ALPRAZOLAM |
| Alprazolam | ALPRAZOLAM | Aphena Pharma Solutions - Tennessee, LLC | 2717699a-c8b6-4590-937a-cb86eadc5296 | 2018-08-23 | Boxed warning, Warnings, Adverse reactions | Alprazolam ALPRAZOLAM |
| Alprazolam | ALPRAZOLAM | Aphena Pharma Solutions - Tennessee, LLC | 964d7f43-34a6-45af-a95f-3b9ade17c6a5 | 2018-02-05 | Boxed warning, Warnings, Adverse reactions | Alprazolam ALPRAZOLAM |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.