Application 077274
- Type
- ANDA
- Sponsor
- EPIC PHARMA LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GLIMEPIRIDE | GLIMEPIRIDE | TABLET;ORAL | 1MG | No | No |
| 002 | GLIMEPIRIDE | GLIMEPIRIDE | TABLET;ORAL | 2MG | No | No |
| 003 | GLIMEPIRIDE | GLIMEPIRIDE | TABLET;ORAL | 4MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077274-001 | GLIMEPIRIDE | GLIMEPIRIDE | 1MG | TABLET / ORAL | 2005-10-06 | ||
| A077274-002 | GLIMEPIRIDE | GLIMEPIRIDE | 2MG | TABLET / ORAL | 2005-10-06 | ||
| A077274-003 | GLIMEPIRIDE | GLIMEPIRIDE | 4MG | TABLET / ORAL | 2005-10-06 |
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 | A077274-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | 2005-10-06 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A077274-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | 2005-10-06 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A077274-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | 2005-10-06 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077274-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | 2005-10-06 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077274-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | 2005-10-06 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077274-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | 2005-10-06 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077274-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | 2005-10-06 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077274-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | 2005-10-06 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077274-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | 2005-10-06 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077274-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | 2005-10-06 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077274-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | 2005-10-06 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077274-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | 2005-10-06 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077274-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | 2005-10-06 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077274-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | 2005-10-06 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077274-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | 2005-10-06 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077274-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | 2005-10-06 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077274-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | 2005-10-06 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077274-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | 2005-10-06 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077274-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | 2005-10-06 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077274-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | 2005-10-06 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077274-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | 2005-10-06 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077274-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | 2005-10-06 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077274-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | 2005-10-06 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077274-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | 2005-10-06 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077274-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | 2005-10-06 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077274-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | 2005-10-06 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077274-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | 2005-10-06 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077274-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | 2005-10-06 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077274-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | 2005-10-06 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077274-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | 2005-10-06 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077274-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | 2005-10-06 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077274-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | 2005-10-06 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077274-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | 2005-10-06 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077274-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | 2005-10-06 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077274-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | 2005-10-06 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077274-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | 2005-10-06 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077274-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | 2005-10-06 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077274-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | 2005-10-06 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077274-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | 2005-10-06 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077274-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | 2005-10-06 | 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 |
|---|---|---|---|---|---|---|
| Glimepiride | GLIMEPIRIDE | A-S Medication Solutions | e8da2484-43a7-4dcb-84d5-d84596feb9f6 | 2023-08-31 | Warnings, Adverse reactions | Glimepiride GLIMEPIRIDE |
| Glimepiride | GLIMEPIRIDE | A-S Medication Solutions | def20e38-01f7-4ead-beb6-3dc11062a342 | 2023-06-22 | Warnings, Adverse reactions | Glimepiride GLIMEPIRIDE |
| Glimepiride | GLIMEPIRIDE | Proficient Rx LP | 8f687fa6-54eb-4556-8ea6-aafec49a87d1 | 2023-03-01 | Warnings, Adverse reactions | Glimepiride GLIMEPIRIDE |
| Glimepiride | GLIMEPIRIDE | Proficient Rx LP | beb0cefb-807b-4cc3-ada2-7a8ed4aa8f2b | 2022-10-01 | Warnings, Adverse reactions | Glimepiride GLIMEPIRIDE |
| Glimepiride | GLIMEPIRIDE | Proficient Rx LP | 5a5747ea-cded-49ed-8807-dd3e2a1159e0 | 2022-10-01 | Warnings, Adverse reactions | Glimepiride GLIMEPIRIDE |
| Glimepiride | GLIMEPIRIDE | Proficient Rx LP | 68cb4fcd-5bc3-4f53-9085-86df6a4246d6 | 2022-04-01 | Warnings, Adverse reactions | Glimepiride GLIMEPIRIDE |
| Glimepiride | GLIMEPIRIDE | Solco Healthcare U.S., LLC | 86acdd9e-8637-43e4-8bf7-b3a123b871b8 | 2021-08-13 | Warnings, Adverse reactions | Glimepiride GLIMEPIRIDE |
| Glimepiride | GLIMEPIRIDE | Bryant Ranch Prepack | ebb9f080-b11d-5d18-36f0-627107e7fbcd | 2020-08-27 | Warnings, Adverse reactions | Glimepiride GLIMEPIRIDE |
| Glimepiride | GLIMEPIRIDE | NCS HealthCare of KY, Inc dba Vangard Labs | 669a67c2-2f97-4b7e-8bba-83a015e0fa94 | 2020-04-30 | Warnings, Adverse reactions | Glimepiride GLIMEPIRIDE |
| Glimepiride | GLIMEPIRIDE | Aphena Pharma Solutions - Tennessee, LLC | 00b9e312-921e-41e6-ad27-0a6ce87f8298 | 2019-02-13 | Warnings, Adverse reactions | Glimepiride GLIMEPIRIDE |
| Glimepiride | GLIMEPIRIDE | Dr. Reddy's Laboratories Limited | 07ad4366-4b21-f633-49f3-c2b35f88168d | 2019-01-16 | Warnings, Adverse reactions | Glimepiride GLIMEPIRIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 9029 | ORIG | 2005-10-10 |