Application 090564
- Type
- ANDA
- Sponsor
- GRANULES INDIA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | TABLET;ORAL | 500MG | No | No |
| 002 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | TABLET;ORAL | 850MG | No | No |
| 003 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | TABLET;ORAL | 1GM | No | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090564-001 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-04-22 | |
| A090564-002 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-04-22 | |
| A090564-003 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | RS | 2010-04-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A090564-001 | AB |
| A090564-002 | AB |
| A090564-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A090564-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-04-22 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A090564-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-04-22 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A090564-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | RS | 2010-04-22 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A090564-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-04-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A090564-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-04-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A090564-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | RS | 2010-04-22 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A090564-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-04-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A090564-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-04-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A090564-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | RS | 2010-04-22 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A090564-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-04-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090564-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-04-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090564-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | RS | 2010-04-22 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090564-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-04-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090564-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-04-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090564-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | RS | 2010-04-22 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090564-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-04-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090564-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-04-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090564-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | RS | 2010-04-22 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090564-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-04-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090564-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-04-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090564-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | RS | 2010-04-22 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090564-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-04-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090564-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-04-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090564-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | RS | 2010-04-22 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090564-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-04-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090564-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-04-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090564-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | RS | 2010-04-22 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090564-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-04-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090564-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-04-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090564-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | RS | 2010-04-22 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090564-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-04-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090564-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-04-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090564-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | RS | 2010-04-22 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090564-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-04-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090564-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-04-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090564-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | RS | 2010-04-22 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090564-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-04-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090564-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-04-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090564-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | RS | 2010-04-22 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090564-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-04-22 | 79d66fd596c7… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A090564-001 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A090564-002 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A090564-003 | AB | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A090564-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A090564-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A090564-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A090564-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A090564-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A090564-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A090564-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090564-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090564-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090564-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090564-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090564-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090564-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090564-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090564-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090564-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090564-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090564-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090564-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090564-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090564-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090564-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090564-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090564-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090564-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090564-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090564-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090564-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090564-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090564-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090564-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090564-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090564-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090564-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090564-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090564-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090564-001 | AB | 1 | 79d66fd596c7… |
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 |
|---|---|---|---|---|---|---|
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | 1c046303-993c-4111-ac9a-40a0d97ca6a2 | 2024-04-30 | Boxed warning, Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | 3c607f04-d36f-4cf8-9cc9-7f2af08b4098 | 2024-01-18 | Boxed warning, Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | 7cc82387-8bb0-4bee-9967-cb13eab1d801 | 2024-01-08 | Boxed warning, Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | d0bc43a4-301f-4002-9b58-bd81dddf2790 | 2023-10-20 | Boxed warning, Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | a4679179-af2d-4c84-a1c8-ab0870a4585d | 2023-10-18 | Boxed warning, Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin HCl | METFORMIN HCL | A-S Medication Solutions | 74f18a3e-0f5c-4172-b499-14f229b431c4 | 2023-09-10 | Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin HCl | METFORMIN HCL | Bryant Ranch Prepack | 4bdd2faa-2125-4139-b958-196393e31b7e | 2023-05-24 | Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin HCl | METFORMIN HCL | A-S Medication Solutions | 4e345b8c-57ab-4f09-9cbe-1d255e9354ba | 2023-03-21 | Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 34aa1761-d16f-4bfc-b7fa-bf1b0387e8a3 | 2022-11-03 | Boxed warning, Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin HCl | METFORMIN HCL | Proficient Rx LP | 53361a39-cb69-483b-a4be-3a4753bf1ba6 | 2022-06-01 | Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Proficient Rx LP | d51f3618-4166-4925-8994-968a653ebc46 | 2022-05-02 | Boxed warning, Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Proficient Rx LP | 5f243894-bda3-4fa9-97e4-209dcb389dee | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin HCl | METFORMIN HCL | Bryant Ranch Prepack | 1f8833f9-1232-4aa7-a0d4-04a9f87dc2f0 | 2021-11-01 | Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Epic Pharma, LLC | 8c1848f9-c113-4552-b6ef-715e72630ad9 | 2019-11-04 | Boxed warning, Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Metcure Pharmaceuticals, Inc. | 5df6adc9-79fd-66ef-e053-2991aa0a75ce | 2018-01-22 | Boxed warning, Adverse reactions | 090564 ANDA090564 |
| Metformin HCl | METFORMIN HCL | Ascend Laboratories, LLC | 2d98aea3-35ba-447a-b88f-a5a20b612b2f | 2017-02-07 | Warnings, Adverse reactions | 090564 ANDA090564 |
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 |
|---|---|---|---|---|---|
| 50742-154 | Metformin hydrochloride | Metformin hydrochloride | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-155 | Metformin hydrochloride | Metformin hydrochloride | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-155 | Metformin hydrochloride | Metformin hydrochloride | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-156 | Metformin hydrochloride | Metformin hydrochloride | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-156 | Metformin hydrochloride | Metformin hydrochloride | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 51655-560 | Metformin hydrochloride | Metformin hydrochloride | Northwind Pharmaceuticals | ANDA | Current |
| 51655-561 | Metformin Hydrochloride | Metformin Hydrochloride | Northwind Pharmaceuticals | ANDA | Current |
| 51655-563 | Metformin hydrochloride | Metformin hydrochloride | Northwind Pharmaceuticals | ANDA | Current |
| 53002-1251 | Metformin hydrochloride | Metformin hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1422 | Metformin hydrochloride | Metformin hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1445 | Metformin hydrochloride | Metformin hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-2251 | Metformin HCl | Metformin HCl | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-2445 | Metformin HCl | Metformin HCl | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 55154-7896 | Metformin hydrochloride | Metformin hydrochloride | Cardinal Health 107, LLC | ANDA | Current |
| 55154-7896 | Metformin hydrochloride | Metformin hydrochloride | Cardinal Health | ANDA | Current |
| 55154-7896 | Metformin hydrochloride | Metformin hydrochloride | Cardinal Health | ANDA | Current |
| 55700-666 | Metformin HCl | Metformin HCl | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-666 | Metformin HCl | Metformin HCl | Quality Care Products, LLC | ANDA | Current |
| 55700-666 | Metformin HCl | Metformin HCl | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-666 | Metformin HCl | Metformin HCl | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-666 | Metformin HCl | Metformin HCl | Lake Erie Medical DBA Qua | ANDA | Current |
| 55700-669 | Metformin HCl | Metformin HCl | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-669 | Metformin HCl | Metformin HCl | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-669 | Metformin HCl | Metformin HCl | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-669 | Metformin HCl | Metformin HCl | Lake Erie Medical DBA Qua | ANDA | Current |
| 55700-669 | Metformin HCl | Metformin HCl | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-924 | Metformin HCl | Metformin HCl | Quality Care Products, LLC | ANDA | Current |
| 58118-0102 | Metformin Hydrochloride | Metformin Hydrochloride | Clinical Solutions Wholesale | ANDA | Current |
| 58118-0102 | Metformin Hydrochloride | Metformin Hydrochloride | Clinical Solutions Wholesale | ANDA | Current |
| 58118-0102 | Metformin Hydrochloride | Metformin Hydrochloride | Clinical Solutions Wholesale | ANDA | Current |
| 58517-040 | Metformin Hydrochloride | Metformin Hydrochloride | New Horizon Rx Group, LLC | ANDA | Current |
| 60760-100 | Metformin hydrochloride | Metformin hydrochloride | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-100 | Metformin hydrochloride | Metformin hydrochloride | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-497 | Metformin Hydrochloride | Metformin Hydrochloride | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-973 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | St Marys Medical Park Pharmacy | ANDA | Current |
| 60760-975 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | St Marys Medical Park Pharmacy | ANDA | Current |
| 61919-313 | METFORMIN Hydrochloride | METFORMIN Hydrochloride | DIRECT RX | ANDA | Current |
| 61919-313 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 61919-313 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Direct_Rx | ANDA | Current |
| 61919-313 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Direct_Rx | ANDA | Current |
| 61919-313 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Direct_Rx | ANDA | Current |
| 61919-313 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 61919-313 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Direct_Rx | ANDA | Current |
| 61919-397 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Direct Rx | ANDA | Current |
| 61919-397 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Direct Rx | ANDA | Current |
| 61919-397 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Direct Rx | ANDA | Current |
| 61919-397 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Direct Rx | ANDA | Current |
| 61919-397 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Direct Rx | ANDA | Current |
| 61919-990 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Direct RX | ANDA | Current |
| 61919-990 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Direct_Rx | ANDA | Current |
| 61919-990 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Direct_Rx | ANDA | Current |
| 61919-990 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Direct_Rx | ANDA | Current |
| 61919-990 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Direct_Rx | ANDA | Current |
| 61919-990 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Direct_Rx | ANDA | Current |
| 61919-990 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Direct_Rx | ANDA | Current |
| 61919-990 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Direct_Rx | ANDA | Current |
| 62207-440 | Metformin Hydrochloride | Metformin Hydrochloride Tablet | Granules India Ltd | ANDA | Current |
| 62207-440 | Metformin Hydrochloride | Metformin Hydrochloride Tablet | Granules India Ltd | ANDA | Current |
| 62207-440 | Metformin Hydrochloride | Metformin Hydrochloride Tablet | Granules India Ltd | ANDA | Current |
| 62207-440 | Metformin Hydrochloride | Metformin Hydrochloride Tablet | Granules India Ltd | ANDA | Current |
| 62207-440 | Metformin Hydrochloride | Metformin Hydrochloride Tablet | Granules India Ltd | ANDA | Current |
| 62207-440 | Metformin Hydrochloride | Metformin Hydrochloride Tablet | Granules India Ltd | ANDA | Current |
| 62207-440 | Metformin Hydrochloride | Metformin Hydrochloride Tablet | Granules India Ltd | ANDA | Current |
| 62207-440 | Metformin Hydrochloride | Metformin Hydrochloride Tablet | Granules India Ltd | ANDA | Current |
| 62207-441 | Metformin Hydrochloride | Metformin Hydrochloride Tablet | Granules India Ltd | ANDA | Current |
| 62207-441 | Metformin Hydrochloride | Metformin Hydrochloride Tablet | Granules India Ltd | ANDA | Current |
| 62207-441 | Metformin Hydrochloride | Metformin Hydrochloride Tablet | Granules India Ltd | ANDA | Current |
| 62207-441 | Metformin Hydrochloride | Metformin Hydrochloride Tablet | Granules India Ltd | ANDA | Current |
| 62207-441 | Metformin Hydrochloride | Metformin Hydrochloride Tablet | Granules India Ltd | ANDA | Current |
| 62207-441 | Metformin Hydrochloride | Metformin Hydrochloride Tablet | Granules India Ltd | ANDA | Current |
| 62207-441 | Metformin Hydrochloride | Metformin Hydrochloride Tablet | Granules India Ltd | ANDA | Current |
| 62207-441 | Metformin Hydrochloride | Metformin Hydrochloride Tablet | Granules India Ltd | ANDA | Current |
| 62207-442 | Metformin Hydrochloride | Metformin Hydrochloride Tablet | Granules India Ltd | ANDA | Current |
| 62207-442 | Metformin Hydrochloride | Metformin Hydrochloride Tablet | Granules India Ltd | ANDA | Current |
| 62207-442 | Metformin Hydrochloride | Metformin Hydrochloride Tablet | Granules India Ltd | ANDA | Current |
| 62207-442 | Metformin Hydrochloride | Metformin Hydrochloride Tablet | Granules India Ltd | ANDA | Current |
| 62207-442 | Metformin Hydrochloride | Metformin Hydrochloride Tablet | Granules India Ltd | ANDA | Current |
| 62207-442 | Metformin Hydrochloride | Metformin Hydrochloride Tablet | Granules India Ltd | ANDA | Current |
| 62207-442 | Metformin Hydrochloride | Metformin Hydrochloride Tablet | Granules India Ltd | ANDA | Current |
| 62207-442 | Metformin Hydrochloride | Metformin Hydrochloride Tablet | Granules India Ltd | ANDA | Current |