Application 077091
- Type
- ANDA
- Sponsor
- DR REDDYS LABS LTD
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 |
|---|---|---|---|---|---|---|---|
| A077091-001 | GLIMEPIRIDE | GLIMEPIRIDE | 1MG | TABLET / ORAL | AB | RS | 2005-10-06 |
| A077091-002 | GLIMEPIRIDE | GLIMEPIRIDE | 2MG | TABLET / ORAL | AB | 2005-10-06 | |
| A077091-003 | GLIMEPIRIDE | GLIMEPIRIDE | 4MG | TABLET / ORAL | AB | 2005-10-06 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077091-001 | AB |
| A077091-002 | AB |
| A077091-003 | 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 | A077091-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | AB | RS | 2005-10-06 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077091-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | AB | 2005-10-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077091-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | AB | 2005-10-06 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077091-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | AB | RS | 2005-10-06 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077091-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | AB | 2005-10-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077091-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | AB | 2005-10-06 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077091-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | AB | RS | 2005-10-06 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077091-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | AB | 2005-10-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077091-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | AB | 2005-10-06 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077091-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | AB | RS | 2005-10-06 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077091-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | AB | 2005-10-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077091-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | AB | 2005-10-06 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077091-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | AB | 2005-10-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077091-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | AB | 2005-10-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077091-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | AB | 2005-10-06 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077091-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | AB | 2005-10-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077091-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | AB | 2005-10-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077091-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | AB | 2005-10-06 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077091-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | AB | 2005-10-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077091-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | AB | 2005-10-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077091-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | AB | 2005-10-06 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077091-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | AB | 2005-10-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077091-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | AB | 2005-10-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077091-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | AB | 2005-10-06 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077091-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | AB | 2005-10-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077091-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | AB | 2005-10-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077091-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | AB | 2005-10-06 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077091-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | AB | 2005-10-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077091-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | AB | 2005-10-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077091-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | AB | 2005-10-06 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077091-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | AB | 2005-10-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077091-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | AB | 2005-10-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077091-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | AB | 2005-10-06 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077091-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | AB | 2005-10-06 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077091-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | AB | 2005-10-06 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077091-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | AB | 2005-10-06 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077091-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | AB | 2005-10-06 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077091-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | AB | 2005-10-06 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077091-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | AB | 2005-10-06 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A077091-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | AB | 2005-10-06 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A077091-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077091-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077091-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077091-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077091-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077091-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077091-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077091-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077091-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077091-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077091-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077091-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077091-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077091-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077091-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077091-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077091-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077091-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077091-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077091-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077091-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077091-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077091-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077091-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077091-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077091-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077091-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077091-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077091-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077091-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077091-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077091-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077091-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077091-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077091-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077091-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077091-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077091-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077091-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A077091-001 | AB | 1 | 8072bd15b7f6… |
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 | Cardinal Health 107, LLC | cc2bc07f-3fab-4df1-85cc-dc0c8e60b4fa | 2026-05-08 | Warnings, Adverse reactions | 077091 ANDA077091 55154-8175 |
| Glimepiride | GLIMEPIRIDE | NuCare Pharmaceuticals,Inc. | bf8e5993-5ee7-d26d-e053-2a95a90ae5df | 2026-02-19 | Warnings, Adverse reactions | 077091 ANDA077091 68071-2385 |
| Glimepiride | GLIMEPIRIDE | AvPAK | 93f1e064-fcbd-e8fd-e053-2995a90a5dbb | 2026-01-14 | Warnings, Adverse reactions | 077091 ANDA077091 50268-358 50268-360 50268-359 |
| Glimepiride | GLIMEPIRIDE | Northwind Health Company, LLC | f3184cd3-df99-db32-e053-2995a90aa573 | 2026-01-01 | Warnings, Adverse reactions | 077091 ANDA077091 |
| Glimepiride | GLIMEPIRIDE | Northwind Health Company, LLC | dae404ac-881a-14d8-e053-2995a90acd41 | 2026-01-01 | Warnings, Adverse reactions | 077091 ANDA077091 |
| Glimepiride | GLIMEPIRIDE | PD-Rx Pharmaceuticals, Inc. | 101cdc41-2131-4425-b550-6a0a60b5f4a4 | 2025-10-15 | Warnings, Adverse reactions | 077091 ANDA077091 |
| Glimepiride | GLIMEPIRIDE | PD-Rx Pharmaceuticals, Inc. | 657f1b51-2f82-44f6-a23d-97f4b34b3c45 | 2025-10-15 | Warnings, Adverse reactions | 077091 ANDA077091 43063-121 |
| Glimepiride | GLIMEPIRIDE | American Health Packaging | 0003458f-352a-46fa-9d99-230daa76ae29 | 2024-11-13 | Warnings, Adverse reactions | 077091 ANDA077091 68084-788 68084-326 68084-327 |
| Glimepiride | GLIMEPIRIDE | Proficient Rx LP | 1f102e4c-1954-4f17-8c60-4dad79f25a25 | 2024-09-01 | Warnings, Adverse reactions | 077091 ANDA077091 |
| Glimepiride | GLIMEPIRIDE | NuCare Pharmaceuticals,Inc. | abc187f1-8645-23e9-e053-2a95a90a64a7 | 2024-07-17 | Warnings, Adverse reactions | 077091 ANDA077091 68071-2228 |
| Glimepiride | GLIMEPIRIDE | A-S Medication Solutions | be772fca-1579-4fba-a4b7-04b970d09e45 | 2023-12-17 | Warnings, Adverse reactions | 077091 ANDA077091 |
| Glimepiride | GLIMEPIRIDE | A-S Medication Solutions | 0a1eaf23-d5fd-4b3e-96c5-68ff16f0033b | 2023-12-14 | Warnings, Adverse reactions | 077091 ANDA077091 |
| Glimepiride | GLIMEPIRIDE | A-S Medication Solutions | a9461830-1c4f-4bc4-b622-1c44112a76b9 | 2023-12-03 | Warnings, Adverse reactions | 077091 ANDA077091 |
| Glimepiride | GLIMEPIRIDE | A-S Medication Solutions | def20e38-01f7-4ead-beb6-3dc11062a342 | 2023-06-22 | Warnings, Adverse reactions | 077091 ANDA077091 |
| Glimepiride | GLIMEPIRIDE | Bryant Ranch Prepack | ebb9f080-b11d-5d18-36f0-627107e7fbcd | 2020-08-27 | Warnings, Adverse reactions | 077091 ANDA077091 63629-3043 |
| Glimepiride | GLIMEPIRIDE | Dr. Reddy's Laboratories Limited | 07ad4366-4b21-f633-49f3-c2b35f88168d | 2019-01-16 | Warnings, Adverse reactions | 077091 ANDA077091 55111-320 55111-321 55111-322 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0615-6575 | Glimepiride | Glimepiride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-6576 | Glimepiride | Glimepiride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7523 | Glimepiride | Glimepiride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 10544-217 | Glimepiride | Glimepiride | Blenheim Pharmacal, Inc. | ANDA | Current |
| 10544-219 | Glimepiride | Glimepiride | Blenheim Pharmacal, Inc. | ANDA | Current |
| 21695-746 | Glimepiride | Glimepiride | Rebel Distributors Corp | ANDA | Current |
| 21695-747 | Glimepiride | Glimepiride | Rebel Distributors Corp | ANDA | Current |
| 21695-993 | Glimepiride | Glimepiride | Rebel Distributors Corp | ANDA | Current |
| 33261-892 | Glimepiride | Glimepiride | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 35356-896 | Glimepiride | Glimepiride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 43063-121 | Glimepiride | Glimepiride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-121 | Glimepiride | Glimepiride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-121 | Glimepiride | Glimepiride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-121 | Glimepiride | Glimepiride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-121 | Glimepiride | Glimepiride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 50268-358 | Glimepiride | Glimepiride | AvPAK | ANDA | Current |
| 50268-358 | Glimepiride | Glimepiride | AvPAK | ANDA | Current |
| 50268-358 | Glimepiride | Glimepiride | AvPAK | ANDA | Current |
| 50268-359 | Glimepiride | Glimepiride | AvPAK | ANDA | Current |
| 50268-359 | Glimepiride | Glimepiride | AvPAK | ANDA | Current |
| 50268-359 | Glimepiride | Glimepiride | AvPAK | ANDA | Current |
| 50268-360 | Glimepiride | Glimepiride | AvPAK | ANDA | Current |
| 50268-360 | Glimepiride | Glimepiride | AvPAK | ANDA | Current |
| 50268-360 | Glimepiride | Glimepiride | AvPAK | ANDA | Current |
| 50436-7073 | Glimepiride | Glimepiride | Unit Dose Services | ANDA | Current |
| 50436-7073 | Glimepiride | Glimepiride | Unit Dose Services | ANDA | Current |
| 50436-7074 | Glimepiride | Glimepiride | Unit Dose Services | ANDA | Current |
| 50436-7075 | Glimepiride | Glimepiride | Unit Dose Services | ANDA | Current |
| 54458-966 | GLIMEPIRIDE | GLIMEPIRIDE | International Laboratories, LLC | ANDA | Current |
| 54458-967 | GLIMEPIRIDE | GLIMEPIRIDE | International Laboratories, LLC | ANDA | Current |
| 55111-320 | Glimepiride | Glimepiride | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-321 | Glimepiride | Glimepiride | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-322 | Glimepiride | Glimepiride | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55154-8175 | Glimepiride | Glimepiride | Cardinal Health | ANDA | Current |
| 55154-8175 | Glimepiride | Glimepiride | Cardinal Health 107, LLC | ANDA | Current |
| 55154-8175 | Glimepiride | Glimepiride | Cardinal Health | ANDA | Current |
| 55154-8175 | Glimepiride | Glimepiride | Cardinal Health | ANDA | Current |
| 55154-8175 | Glimepiride | Glimepiride | Cardinal Health | ANDA | Current |
| 60760-230 | GLIMEPIRIDE | GLIMEPIRIDE | St Marys Medical Park Pharmacy | ANDA | Current |
| 60760-230 | GLIMEPIRIDE | GLIMEPIRIDE | St Marys Medical Park Pharmacy | ANDA | Current |
| 63629-1255 | Glimepiride | Glimepiride | Bryant Ranch Prepack | ANDA | Current |
| 63629-3043 | Glimepiride | Glimepiride | Bryant Ranch Prepack | ANDA | Current |
| 63629-3043 | Glimepiride | Glimepiride | Bryant Ranch Prepack | ANDA | Current |
| 63629-6309 | Glimepiride | Glimepiride | Bryant Ranch Prepack | ANDA | Current |
| 63629-6309 | Glimepiride | Glimepiride | Bryant Ranch Prepack | ANDA | Current |
| 63629-6421 | Glimepiride | Glimepiride | Bryant Ranch Prepack | ANDA | Current |
| 63629-6421 | Glimepiride | Glimepiride | Bryant Ranch Prepack | ANDA | Current |
| 63629-6421 | Glimepiride | Glimepiride | Bryant Ranch Prepack | ANDA | Current |
| 63629-6421 | Glimepiride | Glimepiride | Bryant Ranch Prepack | ANDA | Current |
| 63629-6930 | Glimepiride | Glimepiride | Bryant Ranch Prepack | ANDA | Current |
| 63629-6930 | Glimepiride | Glimepiride | Bryant Ranch Prepack | ANDA | Current |
| 63629-6930 | Glimepiride | Glimepiride | Bryant Ranch Prepack | ANDA | Current |
| 63629-6930 | Glimepiride | Glimepiride | Bryant Ranch Prepack | ANDA | Current |
| 68071-2228 | Glimepiride | Glimepiride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2228 | Glimepiride | Glimepiride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2385 | Glimepiride | Glimepiride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68084-326 | Glimepiride | Glimepiride | American Health Packaging | ANDA | Current |
| 68084-326 | Glimepiride | Glimepiride | American Health Packaging | ANDA | Current |
| 68084-326 | Glimepiride | Glimepiride | American Health Packaging | ANDA | Current |
| 68084-326 | Glimepiride | Glimepiride | American Health Packaging | ANDA | Current |
| 68084-326 | Glimepiride | Glimepiride | American Health Packaging | ANDA | Current |
| 68084-327 | Glimepiride | Glimepiride | American Health Packaging | ANDA | Current |
| 68084-327 | Glimepiride | Glimepiride | American Health Packaging | ANDA | Current |
| 68084-327 | Glimepiride | Glimepiride | American Health Packaging | ANDA | Current |
| 68084-327 | Glimepiride | Glimepiride | American Health Packaging | ANDA | Current |
| 68084-327 | Glimepiride | Glimepiride | American Health Packaging | ANDA | Current |
| 68084-788 | Glimepiride | Glimepiride | American Health Packaging | ANDA | Current |
| 68084-788 | Glimepiride | Glimepiride | American Health Packaging | ANDA | Current |
| 68084-788 | Glimepiride | Glimepiride | American Health Packaging | ANDA | Current |
| 68084-788 | Glimepiride | Glimepiride | American Health Packaging | ANDA | Current |
| 68084-788 | Glimepiride | Glimepiride | American Health Packaging | ANDA | Current |
| 68645-572 | Glimepiride | Glimepiride | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-572 | Glimepiride | Glimepiride | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-572 | Glimepiride | Glimepiride | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-572 | Glimepiride | Glimepiride | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-573 | Glimepiride | Glimepiride | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-573 | Glimepiride | Glimepiride | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-573 | Glimepiride | Glimepiride | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-573 | Glimepiride | Glimepiride | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68788-7694 | Glimepiride | Glimepiride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 9004 | ORIG | 2005-10-11 |