Application 074792
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GLYBURIDE (MICRONIZED) | GLYBURIDE | TABLET;ORAL | 1.5MG | No | No |
| 002 | GLYBURIDE (MICRONIZED) | GLYBURIDE | TABLET;ORAL | 3MG | No | No |
| 003 | GLYBURIDE (MICRONIZED) | GLYBURIDE | TABLET;ORAL | 6MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A074792-001 | GLYBURIDE (MICRONIZED) | GLYBURIDE | 1.5MG | TABLET / ORAL | 1998-06-26 | ||
| A074792-002 | GLYBURIDE (MICRONIZED) | GLYBURIDE | 3MG | TABLET / ORAL | 1998-06-26 | ||
| A074792-003 | GLYBURIDE (MICRONIZED) | GLYBURIDE | 6MG | TABLET / ORAL | 1999-08-17 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2019-12-14 00:12 UTC | 2019-12 | A074792-003 | GLYBURIDE (MICRONIZED) | 6MG | TABLET / ORAL | AB | 1999-08-17 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A074792-001 | GLYBURIDE (MICRONIZED) | 1.5MG | TABLET / ORAL | AB | 1998-06-26 | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | A074792-002 | GLYBURIDE (MICRONIZED) | 3MG | TABLET / ORAL | AB | 1998-06-26 | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | A074792-003 | GLYBURIDE (MICRONIZED) | 6MG | TABLET / ORAL | AB | 1999-08-17 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A074792-001 | GLYBURIDE (MICRONIZED) | 1.5MG | TABLET / ORAL | AB | 1998-06-26 | ea99ee380514… | |
| 2019-07-19 19:46 UTC | 2019-07 | A074792-002 | GLYBURIDE (MICRONIZED) | 3MG | TABLET / ORAL | AB | 1998-06-26 | ea99ee380514… | |
| 2019-07-19 19:46 UTC | 2019-07 | A074792-003 | GLYBURIDE (MICRONIZED) | 6MG | TABLET / ORAL | AB | 1999-08-17 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A074792-001 | GLYBURIDE (MICRONIZED) | 1.5MG | TABLET / ORAL | 1998-06-26 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A074792-002 | GLYBURIDE (MICRONIZED) | 3MG | TABLET / ORAL | 1998-06-26 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A074792-003 | GLYBURIDE (MICRONIZED) | 6MG | TABLET / ORAL | 1999-08-17 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A074792-001 | GLYBURIDE (MICRONIZED) | 1.5MG | TABLET / ORAL | 1998-06-26 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A074792-002 | GLYBURIDE (MICRONIZED) | 3MG | TABLET / ORAL | 1998-06-26 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A074792-003 | GLYBURIDE (MICRONIZED) | 6MG | TABLET / ORAL | 1999-08-17 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A074792-001 | GLYBURIDE (MICRONIZED) | 1.5MG | TABLET / ORAL | 1998-06-26 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A074792-002 | GLYBURIDE (MICRONIZED) | 3MG | TABLET / ORAL | 1998-06-26 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A074792-003 | GLYBURIDE (MICRONIZED) | 6MG | TABLET / ORAL | 1999-08-17 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A074792-001 | GLYBURIDE (MICRONIZED) | 1.5MG | TABLET / ORAL | 1998-06-26 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A074792-002 | GLYBURIDE (MICRONIZED) | 3MG | TABLET / ORAL | 1998-06-26 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A074792-003 | GLYBURIDE (MICRONIZED) | 6MG | TABLET / ORAL | 1999-08-17 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A074792-001 | GLYBURIDE (MICRONIZED) | 1.5MG | TABLET / ORAL | 1998-06-26 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A074792-002 | GLYBURIDE (MICRONIZED) | 3MG | TABLET / ORAL | 1998-06-26 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A074792-003 | GLYBURIDE (MICRONIZED) | 6MG | TABLET / ORAL | 1999-08-17 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A074792-001 | GLYBURIDE (MICRONIZED) | 1.5MG | TABLET / ORAL | 1998-06-26 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A074792-002 | GLYBURIDE (MICRONIZED) | 3MG | TABLET / ORAL | 1998-06-26 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A074792-003 | GLYBURIDE (MICRONIZED) | 6MG | TABLET / ORAL | 1999-08-17 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A074792-001 | GLYBURIDE (MICRONIZED) | 1.5MG | TABLET / ORAL | 1998-06-26 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A074792-002 | GLYBURIDE (MICRONIZED) | 3MG | TABLET / ORAL | 1998-06-26 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A074792-003 | GLYBURIDE (MICRONIZED) | 6MG | TABLET / ORAL | 1999-08-17 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A074792-001 | GLYBURIDE (MICRONIZED) | 1.5MG | TABLET / ORAL | 1998-06-26 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A074792-002 | GLYBURIDE (MICRONIZED) | 3MG | TABLET / ORAL | 1998-06-26 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A074792-003 | GLYBURIDE (MICRONIZED) | 6MG | TABLET / ORAL | 1999-08-17 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A074792-001 | GLYBURIDE (MICRONIZED) | 1.5MG | TABLET / ORAL | 1998-06-26 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A074792-002 | GLYBURIDE (MICRONIZED) | 3MG | TABLET / ORAL | 1998-06-26 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A074792-003 | GLYBURIDE (MICRONIZED) | 6MG | TABLET / ORAL | 1999-08-17 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A074792-001 | GLYBURIDE (MICRONIZED) | 1.5MG | TABLET / ORAL | 1998-06-26 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A074792-002 | GLYBURIDE (MICRONIZED) | 3MG | TABLET / ORAL | 1998-06-26 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A074792-003 | GLYBURIDE (MICRONIZED) | 6MG | TABLET / ORAL | 1999-08-17 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A074792-001 | GLYBURIDE (MICRONIZED) | 1.5MG | TABLET / ORAL | 1998-06-26 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A074792-002 | GLYBURIDE (MICRONIZED) | 3MG | TABLET / ORAL | 1998-06-26 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A074792-003 | GLYBURIDE (MICRONIZED) | 6MG | TABLET / ORAL | 1999-08-17 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A074792-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A074792-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A074792-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | A074792-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A074792-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A074792-003 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A074792-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A074792-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A074792-003 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A074792-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A074792-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A074792-003 | AB | 1 | ea99ee380514… |
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 |
|---|---|---|---|---|---|---|
| Glyburide | GLYBURIDE | REMEDYREPACK INC. | 524eec41-37ee-419a-b7a1-d23e888ae6ab | 2026-06-12 | Warnings, Adverse reactions | GLYBURIDE |
| GLYBURIDE | GLYBURIDE | Bryant Ranch Prepack | 9cdd30e7-512a-4f00-a4de-0a154d143ce9 | 2026-05-18 | Adverse reactions | GLYBURIDE |
| Glyburide | GLYBURIDE | REMEDYREPACK INC. | e23b9a3b-0184-4d1c-8e2c-668697a6da87 | 2026-05-15 | Warnings, Adverse reactions | GLYBURIDE |
| Glyburide | GLYBURIDE | Preferred Pharmaceuticals Inc. | cf21c8c0-7247-4d5b-97f8-ae4016144642 | 2026-05-07 | Warnings, Adverse reactions | GLYBURIDE |
| Glyburide | GLYBURIDE | Preferred Pharmaceuticals Inc. | bc8df889-25e0-49a0-bbec-a3dfae8bbb8a | 2026-01-27 | Warnings, Adverse reactions | GLYBURIDE |
| Glyburide | GLYBURIDE | A-S Medication Solutions | 51cf08e2-8a2f-4bde-996f-f431f1a68abd | 2026-01-20 | Warnings, Adverse reactions | GLYBURIDE |
| Glyburide | GLYBURIDE | NuCare Pharmaceuticals,Inc. | ffd31d06-6011-34e2-e053-6394a90a437f | 2026-01-16 | Warnings, Adverse reactions | GLYBURIDE |
| GLYBURIDE | GLYBURIDE | Northwind Health Company, LLC | d9cb9251-7b31-72a0-e053-2a95a90a4315 | 2026-01-01 | Adverse reactions | GLYBURIDE |
| GLYBURIDE | GLYBURIDE | Northwind Health Company, LLC | db47a517-f8bb-136f-e053-2a95a90ad8c5 | 2026-01-01 | Adverse reactions | GLYBURIDE |
| GLYBURIDE | GLYBURIDE | Chartwell RX, LLC | 7e661288-2d24-4403-86a1-754afa1d04ff | 2025-12-09 | Adverse reactions | GLYBURIDE |
| Glyburide | GLYBURIDE | Coupler LLC | 4573af7f-3c71-e323-e063-6394a90aa9eb | 2025-12-08 | Warnings, Adverse reactions | GLYBURIDE |
| GLYBURIDE | GLYBURIDE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 33418bba-c5ea-4c0f-9d28-31dc2724c6c3 | 2025-10-31 | Adverse reactions | GLYBURIDE |
| Glyburide | GLYBURIDE | Bryant Ranch Prepack | db074991-1267-454a-8b1d-b6f52e2132cc | 2025-10-03 | Warnings, Adverse reactions | GLYBURIDE |
| Glyburide | GLYBURIDE | Proficient Rx LP | 6f65131c-90df-45ab-95fb-c36f411c6fbe | 2025-07-01 | Warnings, Adverse reactions | GLYBURIDE |
| Glyburide | GLYBURIDE | NuCare Pharmaceuticals,Inc. | 7ee41cd3-461f-3408-e053-2991aa0a863d | 2025-02-06 | Adverse reactions | GLYBURIDE |
| GLYBURIDE | GLYBURIDE | Bryant Ranch Prepack | 05341afe-5b7a-462a-a196-689cb09f83fc | 2025-01-28 | Adverse reactions | GLYBURIDE |
| Glyburide | GLYBURIDE | A-S Medication Solutions | 676c0e45-0aa2-4060-ad18-67abb9873a50 | 2024-10-28 | Warnings, Adverse reactions | GLYBURIDE |
| Glyburide | GLYBURIDE | NuCare Pharmaceuticals, Inc. | 25516c2a-f1b5-9ee4-e063-6394a90ab46b | 2024-10-25 | Warnings, Adverse reactions | GLYBURIDE |
| Glyburide | GLYBURIDE | NuCare Pharmaceuticals, Inc. | 21786ac0-da3c-16cb-e063-6394a90a4596 | 2024-09-06 | Warnings, Adverse reactions | GLYBURIDE |
| Glyburide | GLYBURIDE | NuCare Pharmaceuticals, Inc. | 3e354b4d-70e4-5089-e054-00144ff88e88 | 2024-08-13 | Adverse reactions | GLYBURIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-1113 | Glyburide | glyburide | Mylan Pharmaceuticals Inc | ANDA | Current |
| 0378-1113 | Glyburide | glyburide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1125 | Glyburide | glyburide | Mylan Pharmaceuticals Inc | ANDA | Current |
| 0378-1125 | Glyburide | glyburide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1142 | Glyburide | glyburide | Mylan Pharmaceuticals Inc | ANDA | Current |
| 0378-1142 | Glyburide | glyburide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 43063-119 | Glyburide | glyburide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-120 | Glyburide | glyburide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8445 | ORIG | 1998-06-26 |