Application 214874
- Type
- ANDA
- Sponsor
- RUBICON RESEARCH
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GLIPIZIDE | GLIPIZIDE | TABLET;ORAL | 2.5MG | No | No |
| 002 | GLIPIZIDE | GLIPIZIDE | TABLET;ORAL | 5MG | No | No |
| 003 | GLIPIZIDE | GLIPIZIDE | TABLET;ORAL | 10MG | No | No |
| 004 | GLIPIZIDE | GLIPIZIDE | TABLET;ORAL | 15MG | No | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A214874-001 | GLIPIZIDE | GLIPIZIDE | 2.5MG | TABLET / ORAL | 2023-10-03 | ||
| A214874-002 | GLIPIZIDE | GLIPIZIDE | 5MG | TABLET / ORAL | AB | 2023-10-03 | |
| A214874-003 | GLIPIZIDE | GLIPIZIDE | 10MG | TABLET / ORAL | AB | 2023-10-03 | |
| A214874-004 | GLIPIZIDE | GLIPIZIDE | 15MG | TABLET / ORAL | RS | 2026-02-04 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A214874-002 | AB |
| A214874-003 | 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 | A214874-001 | GLIPIZIDE | 2.5MG | TABLET / ORAL | 2023-10-03 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A214874-002 | GLIPIZIDE | 5MG | TABLET / ORAL | AB | 2023-10-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A214874-003 | GLIPIZIDE | 10MG | TABLET / ORAL | AB | 2023-10-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A214874-004 | GLIPIZIDE | 15MG | TABLET / ORAL | RS | 2026-02-04 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214874-001 | GLIPIZIDE | 2.5MG | TABLET / ORAL | 2023-10-03 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214874-002 | GLIPIZIDE | 5MG | TABLET / ORAL | AB | 2023-10-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214874-003 | GLIPIZIDE | 10MG | TABLET / ORAL | AB | 2023-10-03 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A214874-001 | GLIPIZIDE | 2.5MG | TABLET / ORAL | 2023-10-03 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A214874-002 | GLIPIZIDE | 5MG | TABLET / ORAL | AB | 2023-10-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A214874-003 | GLIPIZIDE | 10MG | TABLET / ORAL | AB | 2023-10-03 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214874-001 | GLIPIZIDE | 2.5MG | TABLET / ORAL | 2023-10-03 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214874-002 | GLIPIZIDE | 5MG | TABLET / ORAL | AB | 2023-10-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214874-003 | GLIPIZIDE | 10MG | TABLET / ORAL | AB | 2023-10-03 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214874-001 | GLIPIZIDE | 2.5MG | TABLET / ORAL | 2023-10-03 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214874-002 | GLIPIZIDE | 5MG | TABLET / ORAL | AB | 2023-10-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214874-003 | GLIPIZIDE | 10MG | TABLET / ORAL | AB | 2023-10-03 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214874-001 | GLIPIZIDE | 2.5MG | TABLET / ORAL | 2023-10-03 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214874-002 | GLIPIZIDE | 5MG | TABLET / ORAL | AB | 2023-10-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214874-003 | GLIPIZIDE | 10MG | TABLET / ORAL | AB | 2023-10-03 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214874-001 | GLIPIZIDE | 2.5MG | TABLET / ORAL | 2023-10-03 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214874-002 | GLIPIZIDE | 5MG | TABLET / ORAL | AB | 2023-10-03 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214874-003 | GLIPIZIDE | 10MG | TABLET / ORAL | AB | 2023-10-03 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214874-001 | GLIPIZIDE | 2.5MG | TABLET / ORAL | 2023-10-03 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214874-002 | GLIPIZIDE | 5MG | TABLET / ORAL | AB | 2023-10-03 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214874-003 | GLIPIZIDE | 10MG | TABLET / ORAL | AB | 2023-10-03 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214874-001 | GLIPIZIDE | 2.5MG | TABLET / ORAL | 2023-10-03 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214874-002 | GLIPIZIDE | 5MG | TABLET / ORAL | AB | 2023-10-03 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214874-003 | GLIPIZIDE | 10MG | TABLET / ORAL | AB | 2023-10-03 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A214874-001 | GLIPIZIDE | 2.5MG | TABLET / ORAL | 2023-10-03 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A214874-002 | GLIPIZIDE | 5MG | TABLET / ORAL | AB | 2023-10-03 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A214874-003 | GLIPIZIDE | 10MG | TABLET / ORAL | AB | 2023-10-03 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A214874-001 | GLIPIZIDE | 2.5MG | TABLET / ORAL | 2023-10-03 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A214874-002 | GLIPIZIDE | 5MG | TABLET / ORAL | AB | 2023-10-03 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A214874-003 | GLIPIZIDE | 10MG | TABLET / ORAL | AB | 2023-10-03 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A214874-001 | GLIPIZIDE | 2.5MG | TABLET / ORAL | 2023-10-03 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A214874-002 | GLIPIZIDE | 5MG | TABLET / ORAL | AB | 2023-10-03 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A214874-003 | GLIPIZIDE | 10MG | TABLET / ORAL | AB | 2023-10-03 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A214874-001 | GLIPIZIDE | 2.5MG | TABLET / ORAL | 2023-10-03 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A214874-002 | GLIPIZIDE | 5MG | TABLET / ORAL | AB | 2023-10-03 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A214874-003 | GLIPIZIDE | 10MG | TABLET / ORAL | AB | 2023-10-03 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A214874-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A214874-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214874-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214874-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A214874-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A214874-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214874-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214874-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214874-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214874-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214874-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214874-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214874-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214874-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214874-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214874-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214874-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214874-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A214874-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A214874-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A214874-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A214874-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A214874-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A214874-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A214874-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A214874-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A214874-002 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A214874-003 | AB | 1 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A214874-002 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A214874-003 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A214874-002 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A214874-003 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A214874-002 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A214874-003 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A214874-002 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A214874-003 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A214874-002 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A214874-003 | AB | 1 | 9b2671bbb829… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A214874-002 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A214874-003 | AB | 1 | a50c72e98297… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214874-001 | CGT | 2024-04-15 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214874-001 | CGT | 2024-04-15 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214874-001 | CGT | 2024-04-15 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214874-001 | CGT | 2024-04-15 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A214874-001 | CGT | 2024-04-15 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A214874-001 | CGT | 2024-04-15 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A214874-001 | CGT | 2024-04-15 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A214874-001 | CGT | 2024-04-15 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A214874-001 | CGT | 2024-04-15 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A214874-001 | CGT | 2024-04-15 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A214874-001 | CGT | 2024-04-15 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A214874-001 | CGT | 2024-04-15 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A214874-001 | CGT | 2024-04-15 | a72a2bbeb626… |
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 |
|---|---|---|---|---|---|---|
| Glipizide | GLIPIZIDE | NuCare Pharmaceuticals, Inc. | 4c4dfe64-d1c5-65ec-e063-6394a90aead5 | 2026-06-19 | Warnings, Adverse reactions | 214874 ANDA214874 |
| Glipizide | GLIPIZIDE | Bryant Ranch Prepack | 06fb6c56-5609-41d9-8389-eba81432218d | 2026-06-11 | Warnings, Adverse reactions | 214874 ANDA214874 |
| Glipizide | GLIPIZIDE | Bryant Ranch Prepack | 5ca7e38b-84cb-4043-b97e-e2f5cd82b442 | 2026-06-11 | Warnings, Adverse reactions | 214874 ANDA214874 |
| Glipizide | GLIPIZIDE | PD-Rx Pharmaceuticals, Inc. | c8cfd137-7b41-460f-a463-141c9d1985ff | 2026-06-04 | Warnings, Adverse reactions | 214874 ANDA214874 |
| Glipizide | GLIPIZIDE | A-S Medication Solutions | 69a21bd3-3364-4035-b098-3808cc8cf8b2 | 2026-05-17 | Warnings, Adverse reactions | 214874 ANDA214874 |
| Glipizide | GLIPIZIDE | A-S Medication Solutions | c582d7d0-4db0-4296-8131-baefd1a671b2 | 2026-05-17 | Warnings, Adverse reactions | 214874 ANDA214874 |
| Glipizide | GLIPIZIDE | PD-Rx Pharmaceuticals, Inc. | d9b6464f-6fe6-446e-8150-d0c15c46fee8 | 2026-03-23 | Warnings, Adverse reactions | 214874 ANDA214874 |
| Glipizide | GLIPIZIDE | PD-Rx Pharmaceuticals, Inc. | 3de8b0a7-b848-40af-8406-fe6924ff41db | 2026-03-23 | Warnings, Adverse reactions | 214874 ANDA214874 |
| Glipizide | GLIPIZIDE | Advagen Pharma Limited | e954afb8-52eb-416a-8f1b-14b0fcb3bac2 | 2026-03-06 | Warnings, Adverse reactions | 214874 ANDA214874 |
| Glipizide | GLIPIZIDE | A-S Medication Solutions | 3b111484-78ef-4db9-95ee-6cc4b6acdd59 | 2025-11-01 | Warnings, Adverse reactions | 214874 ANDA214874 |
| Glipizide | GLIPIZIDE | A-S Medication Solutions | 155216cf-4bad-479a-83b6-032d4bd11c2e | 2025-11-01 | Warnings, Adverse reactions | 214874 ANDA214874 |
| Glipizide | GLIPIZIDE | Advanced Rx of Tennessee, LLC | 3d87cc75-7a0d-46a2-e063-6294a90a6d49 | 2025-08-29 | Warnings, Adverse reactions | 214874 ANDA214874 |
| Glipizide | GLIPIZIDE | Preferred Pharmaceuticals Inc. | 4d490a3a-abdc-4ff4-83fb-f302f51e3023 | 2025-08-29 | Warnings, Adverse reactions | 214874 ANDA214874 |
| Glipizide | GLIPIZIDE | Proficient Rx LP | 6427db20-6783-439f-8c2d-64d1a6fcb9fc | 2025-02-01 | Warnings, Adverse reactions | 214874 ANDA214874 |
| Glipizide | GLIPIZIDE | TruPharma LLC | 95ea4c96-84b9-4515-9494-a93d26820f70 | 2023-10-11 | Warnings, Adverse reactions | 214874 ANDA214874 |