Application 018276
- Type
- NDA
- Sponsor
- PHARMACIA AND UPJOHN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | XANAX | ALPRAZOLAM | TABLET;ORAL | 0.25MG | Yes | No |
| 002 | XANAX | ALPRAZOLAM | TABLET;ORAL | 0.5MG | Yes | No |
| 003 | XANAX | ALPRAZOLAM | TABLET;ORAL | 1MG | Yes | Yes |
| 004 | XANAX | ALPRAZOLAM | TABLET;ORAL | 2MG | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N018276-001 | XANAX | ALPRAZOLAM | 0.25MG | TABLET / ORAL | AB | RLD, Approved before 1982 | |
| N018276-002 | XANAX | ALPRAZOLAM | 0.5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | |
| N018276-003 | XANAX | ALPRAZOLAM | 1MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | |
| N018276-004 | XANAX | ALPRAZOLAM | 2MG | TABLET / ORAL | AB | RLD | 1985-11-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N018276-001 | AB |
| N018276-002 | AB |
| N018276-003 | AB |
| N018276-004 | AB |
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 | N018276-001 | XANAX | 0.25MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018276-002 | XANAX | 0.5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018276-003 | XANAX | 1MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018276-004 | XANAX | 2MG | TABLET / ORAL | AB | RLD | 1985-11-27 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018276-001 | XANAX | 0.25MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018276-002 | XANAX | 0.5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018276-003 | XANAX | 1MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018276-004 | XANAX | 2MG | TABLET / ORAL | AB | RLD | 1985-11-27 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N018276-001 | XANAX | 0.25MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018276-002 | XANAX | 0.5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018276-003 | XANAX | 1MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018276-004 | XANAX | 2MG | TABLET / ORAL | AB | RLD | 1985-11-27 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018276-001 | XANAX | 0.25MG | TABLET / ORAL | AB | RLD, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018276-002 | XANAX | 0.5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018276-003 | XANAX | 1MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018276-004 | XANAX | 2MG | TABLET / ORAL | AB | RLD | 1985-11-27 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018276-001 | XANAX | 0.25MG | TABLET / ORAL | AB | RLD, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018276-002 | XANAX | 0.5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018276-003 | XANAX | 1MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018276-004 | XANAX | 2MG | TABLET / ORAL | AB | RLD | 1985-11-27 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018276-001 | XANAX | 0.25MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018276-002 | XANAX | 0.5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018276-003 | XANAX | 1MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018276-004 | XANAX | 2MG | TABLET / ORAL | AB | RLD | 1985-11-27 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018276-001 | XANAX | 0.25MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018276-002 | XANAX | 0.5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018276-003 | XANAX | 1MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018276-004 | XANAX | 2MG | TABLET / ORAL | AB | RLD | 1985-11-27 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018276-001 | XANAX | 0.25MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018276-002 | XANAX | 0.5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018276-003 | XANAX | 1MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018276-004 | XANAX | 2MG | TABLET / ORAL | AB | RLD | 1985-11-27 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018276-001 | XANAX | 0.25MG | TABLET / ORAL | AB | RLD, Approved before 1982 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018276-002 | XANAX | 0.5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018276-003 | XANAX | 1MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018276-004 | XANAX | 2MG | TABLET / ORAL | AB | RLD | 1985-11-27 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N018276-001 | XANAX | 0.25MG | TABLET / ORAL | AB | RLD, Approved before 1982 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N018276-002 | XANAX | 0.5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N018276-003 | XANAX | 1MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N018276-004 | XANAX | 2MG | TABLET / ORAL | AB | RLD | 1985-11-27 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N018276-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N018276-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N018276-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N018276-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018276-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018276-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018276-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018276-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N018276-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N018276-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N018276-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N018276-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018276-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018276-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018276-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018276-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018276-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018276-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018276-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018276-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018276-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018276-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018276-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018276-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018276-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018276-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018276-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018276-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018276-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018276-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018276-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018276-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018276-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018276-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018276-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018276-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N018276-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N018276-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N018276-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N018276-004 | AB | 1 | d06236e962d9… |
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 | ALPRAZOLAM | Mylan Pharmaceuticals Inc. | 13930c94-d83a-414f-be35-b1fef35f738d | 2025-01-15 | Boxed warning, Warnings, Adverse reactions | 018276 NDA018276 59762-3720 59762-3721 59762-3719 59762-3722 |
| Xanax | ALPRAZOLAM | Viatris Specialty LLC | bb5cf72e-3a41-41a8-9a38-80f974eca33f | 2024-04-15 | Boxed warning, Warnings, Adverse reactions | 018276 NDA018276 |
| Alprazolam | ALPRAZOLAM | Asclemed USA, Inc. | e3245259-024f-4bd9-9ec6-94aa11febfd7 | 2024-01-11 | Boxed warning, Warnings, Adverse reactions | 018276 NDA018276 |
| Alprazolam | ALPRAZOLAM | Proficient Rx LP | 60c90b4b-174f-4fd2-b65f-fc166c16bdc1 | 2023-10-01 | Boxed warning, Warnings, Adverse reactions | 018276 NDA018276 |
| Alprazolam | ALPRAZOLAM | Proficient Rx LP | 10de2b3b-3b3f-4a5a-a9e7-a8401f53b8cc | 2023-08-04 | Boxed warning, Warnings, Adverse reactions | 018276 NDA018276 71205-614 |
| Xanax | ALPRAZOLAM | PHARMACIA & UPJOHN COMPANY LLC | 388e249d-b9b6-44c3-9f8f-880eced0239f | 2023-01-18 | Boxed warning, Warnings, Adverse reactions | 018276 NDA018276 0009-0090 0009-0055 0009-0029 0009-0094 |
| Alprazolam | ALPRAZOLAM | Proficient Rx LP | 4579facb-b225-4108-a5ef-dada926ef7cf | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | 018276 NDA018276 71205-652 |
| Alprazolam | ALPRAZOLAM | Proficient Rx LP | f6990b57-7011-4cdf-8abc-1794e2e0c7f1 | 2019-11-01 | Boxed warning, Warnings, Adverse reactions | 018276 NDA018276 63187-971 |
| Alprazolam | ALPRAZOLAM | Aphena Pharma Solutions - Tennessee, LLC | 964d7f43-34a6-45af-a95f-3b9ade17c6a5 | 2018-02-05 | Boxed warning, Warnings, Adverse reactions | 018276 NDA018276 67544-414 67544-415 67544-347 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0009-0029 | Xanax | alprazolam | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0029 | Xanax | alprazolam | Pharmacia & Upjohn Company LLC | NDA | Current |
| 0009-0029 | Xanax | alprazolam | Pharmacia & Upjohn Company LLC | NDA | Current |
| 0009-0029 | Xanax | alprazolam | Pharmacia & Upjohn Company LLC | NDA | Current |
| 0009-0029 | Xanax | alprazolam | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0029 | Xanax | alprazolam | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0055 | Xanax | alprazolam | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0055 | Xanax | alprazolam | Pharmacia & Upjohn Company LLC | NDA | Current |
| 0009-0055 | Xanax | alprazolam | Pharmacia & Upjohn Company LLC | NDA | Current |
| 0009-0055 | Xanax | alprazolam | Pharmacia & Upjohn Company LLC | NDA | Current |
| 0009-0055 | Xanax | alprazolam | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0055 | Xanax | alprazolam | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0090 | Xanax | alprazolam | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0090 | Xanax | alprazolam | Pharmacia & Upjohn Company LLC | NDA | Current |
| 0009-0090 | Xanax | alprazolam | Pharmacia & Upjohn Company LLC | NDA | Current |
| 0009-0090 | Xanax | alprazolam | Pharmacia & Upjohn Company LLC | NDA | Current |
| 0009-0090 | Xanax | alprazolam | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0090 | Xanax | alprazolam | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0094 | Xanax | alprazolam | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0094 | Xanax | alprazolam | Pharmacia & Upjohn Company LLC | NDA | Current |
| 0009-0094 | Xanax | alprazolam | Pharmacia & Upjohn Company LLC | NDA | Current |
| 0009-0094 | Xanax | alprazolam | Pharmacia & Upjohn Company LLC | NDA | Current |
| 0009-0094 | Xanax | alprazolam | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0094 | Xanax | alprazolam | Pharmacia and Upjohn Company LLC | NDA | Current |
| 49999-252 | Alprazolam | Alprazolam | Quality Care Products LLC | NDA AUTHORIZED GENERIC | Current |
| 49999-252 | Alprazolam | Alprazolam | Quality Care Products LLC | NDA AUTHORIZED GENERIC | Current |
| 49999-252 | Alprazolam | Alprazolam | Quality Care Products LLC | NDA AUTHORIZED GENERIC | Current |
| 50090-4950 | Alprazolam | alprazolam | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 50090-4950 | Alprazolam | alprazolam | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 53002-0340 | Alprazolam | alprazolam | RPK Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 53002-0340 | Alprazolam | alprazolam | RPK Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 59762-3719 | Alprazolam | alprazolam | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-3719 | Alprazolam | alprazolam | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-3719 | Alprazolam | alprazolam | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-3719 | Alprazolam | alprazolam | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-3719 | Alprazolam | alprazolam | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-3720 | Alprazolam | alprazolam | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-3720 | Alprazolam | alprazolam | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-3720 | Alprazolam | alprazolam | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-3720 | Alprazolam | alprazolam | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-3720 | Alprazolam | alprazolam | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-3721 | Alprazolam | alprazolam | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-3721 | Alprazolam | alprazolam | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-3721 | Alprazolam | alprazolam | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-3721 | Alprazolam | alprazolam | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-3721 | Alprazolam | alprazolam | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-3722 | Alprazolam | alprazolam | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-3722 | Alprazolam | alprazolam | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-3722 | Alprazolam | alprazolam | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-3722 | Alprazolam | alprazolam | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-3722 | Alprazolam | alprazolam | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 63187-971 | Alprazolam | alprazolam | Proficient Rx LP | NDA AUTHORIZED GENERIC | Current |
| 63187-971 | Alprazolam | alprazolam | Proficient Rx LP | NDA AUTHORIZED GENERIC | Current |
| 63629-3308 | Alprazolam | alprazolam | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 67046-963 | Alprazolam | alprazolam | Contract Pharmacy Services-PA | NDA AUTHORIZED GENERIC | Current |
| 67046-964 | Alprazolam | alprazolam | Contract Pharmacy Services-PA | NDA AUTHORIZED GENERIC | Current |
| 67046-965 | Alprazolam | alprazolam | Contract Pharmacy Services-PA | NDA AUTHORIZED GENERIC | Current |
| 67544-347 | Alprazolam | alprazolam | Aphena Pharma Solutions - Tennessee, LLC | NDA AUTHORIZED GENERIC | Current |
| 67544-414 | Alprazolam | alprazolam | Aphena Pharma Solutions - Tennessee, LLC | NDA AUTHORIZED GENERIC | Current |
| 67544-415 | Alprazolam | alprazolam | Aphena Pharma Solutions - Tennessee, LLC | NDA AUTHORIZED GENERIC | Current |
| 70518-2785 | Alprazolam | alprazolam | REMEDYREPACK INC. | NDA AUTHORIZED GENERIC | Current |
| 70518-2785 | Alprazolam | alprazolam | REMEDYREPACK INC. | NDA AUTHORIZED GENERIC | Current |
| 71205-614 | Alprazolam | alprazolam | Proficient Rx LP | NDA AUTHORIZED GENERIC | Current |
| 71205-652 | Alprazolam | alprazolam | Proficient Rx LP | NDA AUTHORIZED GENERIC | Current |
| 72789-087 | Alprazolam | alprazolam | PD-Rx Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 72789-087 | Alprazolam | alprazolam | PD-Rx Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 72789-087 | Alprazolam | alprazolam | PD-Rx Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 72789-087 | Alprazolam | alprazolam | PD-Rx Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 72789-087 | Alprazolam | alprazolam | PD-Rx Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 73417 | SUPPL | 2023-02-08 |
| 73234 | SUPPL | 2023-01-17 |
| 73233 | SUPPL | 2023-01-17 |
| 73174 | SUPPL | 2023-01-17 |
| 73173 | SUPPL | 2023-01-17 |
| 66455 | SUPPL | 2021-03-02 |
| 66448 | SUPPL | 2021-03-02 |
| 66190 | SUPPL | 2021-02-11 |
| 66189 | SUPPL | 2021-02-11 |
| 66131 | SUPPL | 2021-02-09 |
| 46632 | SUPPL | 2016-12-30 |
| 46465 | SUPPL | 2016-12-22 |
| 46243 | SUPPL | 2016-12-20 |
| 886 | SUPPL | 2011-08-26 |
| 11189 | SUPPL | 2011-08-24 |
| 33466 | SUPPL | 2011-06-07 |
| 885 | SUPPL | 2011-06-03 |
| 40793 | SUPPL | 2006-10-25 |
| 40792 | SUPPL | 2006-10-25 |
| 40791 | SUPPL | 2006-10-25 |
| 14963 | SUPPL | 2004-04-07 |
| 884 | SUPPL | 2004-04-07 |
| 20121 | SUPPL | 1997-11-20 |