Application 203769
- Type
- ANDA
- Sponsor
- SCIEGEN PHARMS INC
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 | No |
| 004 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | TABLET;ORAL | 625MG | No | No |
| 005 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | TABLET;ORAL | 750MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A203769-001 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2013-09-11 | |
| A203769-002 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2013-09-11 | |
| A203769-003 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2013-09-11 | |
| A203769-004 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 625MG | TABLET / ORAL | AB | 2026-02-09 | |
| A203769-005 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 750MG | TABLET / ORAL | AB | 2026-02-09 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A203769-001 | AB |
| A203769-002 | AB |
| A203769-003 | AB |
| A203769-004 | AB |
| A203769-005 | 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 | A203769-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2013-09-11 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A203769-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2013-09-11 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A203769-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2013-09-11 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A203769-004 | METFORMIN HYDROCHLORIDE | 625MG | TABLET / ORAL | AB | 2026-02-09 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A203769-005 | METFORMIN HYDROCHLORIDE | 750MG | TABLET / ORAL | AB | 2026-02-09 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A203769-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2013-09-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A203769-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2013-09-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A203769-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2013-09-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A203769-004 | METFORMIN HYDROCHLORIDE | 625MG | TABLET / ORAL | AB | 2026-02-09 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A203769-005 | METFORMIN HYDROCHLORIDE | 750MG | TABLET / ORAL | AB | 2026-02-09 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A203769-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2013-09-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A203769-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2013-09-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A203769-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2013-09-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A203769-004 | METFORMIN HYDROCHLORIDE | 625MG | TABLET / ORAL | AB | 2026-02-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A203769-005 | METFORMIN HYDROCHLORIDE | 750MG | TABLET / ORAL | AB | 2026-02-09 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203769-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2013-09-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203769-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2013-09-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203769-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2013-09-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203769-004 | METFORMIN HYDROCHLORIDE | 625MG | TABLET / ORAL | AB | 2026-02-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203769-005 | METFORMIN HYDROCHLORIDE | 750MG | TABLET / ORAL | AB | 2026-02-09 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203769-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2013-09-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203769-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2013-09-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203769-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2013-09-11 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203769-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2013-09-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203769-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2013-09-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203769-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2013-09-11 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203769-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2013-09-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203769-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2013-09-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203769-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2013-09-11 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203769-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2013-09-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203769-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2013-09-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203769-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2013-09-11 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203769-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2013-09-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203769-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2013-09-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203769-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2013-09-11 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203769-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2013-09-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203769-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2013-09-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203769-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2013-09-11 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203769-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2013-09-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203769-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2013-09-11 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A203769-001 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A203769-002 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A203769-003 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A203769-004 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A203769-005 | AB | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A203769-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A203769-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A203769-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A203769-004 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A203769-005 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A203769-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A203769-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A203769-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A203769-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A203769-005 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A203769-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203769-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203769-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203769-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203769-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203769-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203769-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203769-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A203769-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203769-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203769-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203769-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203769-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203769-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203769-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203769-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203769-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203769-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203769-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203769-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203769-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203769-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203769-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203769-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203769-002 | AB | 1 | 5bbf6a4d5a75… |
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 | Golden State Medical Supply, Inc. | f86bda10-8b25-4125-8bb1-1b5917969ff0 | 2023-03-21 | Boxed warning, Warnings, Adverse reactions | 203769 ANDA203769 |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | 76879512-3ab4-4acf-92e6-bba0fb75dd0e | 2023-03-10 | Boxed warning, Warnings, Adverse reactions | 203769 ANDA203769 |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | a59327bd-a3ba-417b-9e91-4cd3a941e640 | 2023-03-10 | Boxed warning, Warnings, Adverse reactions | 203769 ANDA203769 |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | a79d2674-071f-4641-9b11-406e02c5530a | 2023-03-10 | Boxed warning, Warnings, Adverse reactions | 203769 ANDA203769 |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | d0bee456-c8cd-46a1-acb3-5313a8cddd30 | 2022-11-03 | Boxed warning, Warnings, Adverse reactions | 203769 ANDA203769 71610-672 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Proficient Rx LP | 738402d6-3700-46b2-a90c-2e8f2c354a39 | 2022-03-01 | Boxed warning, Warnings, Adverse reactions | 203769 ANDA203769 71205-882 71205-883 71205-884 |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | 9632456f-57c2-444b-9f43-d9ca862681fe | 2021-03-10 | Boxed warning, Warnings, Adverse reactions | 203769 ANDA203769 71335-1785 |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | ACI Healthcare USA, Inc. | e18b60f9-721e-4db6-9f61-d3437e18faf2 | 2020-12-26 | Boxed warning, Warnings, Adverse reactions | 203769 ANDA203769 71093-132 71093-134 71093-133 |
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 |
|---|---|---|---|---|---|
| 68071-2386 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2388 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2398 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2413 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2490 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2595 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7901 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc | ANDA | Current |
| 68788-7901 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc | ANDA | Current |
| 68788-8083 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc | ANDA | Current |
| 68788-8083 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc | ANDA | Current |
| 68788-8110 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-8110 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 69367-180 | Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-180 | Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-181 | Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-181 | Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-182 | Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-182 | Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 70518-1453 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-1453 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-1768 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-1768 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-1768 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-1951 | Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-1951 | Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70934-404 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-404 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-404 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-422 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-422 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-422 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-427 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-427 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-427 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-576 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Current |
| 71093-132 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-132 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-132 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-132 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-133 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-133 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-133 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-133 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-134 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-134 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-134 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-134 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | ACI Healthcare USA, Inc. | ANDA | Current |
| 71205-882 | Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Proficient Rx LP | ANDA | Current |
| 71205-882 | Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Proficient Rx LP | ANDA | Current |
| 71205-883 | Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Proficient Rx LP | ANDA | Current |
| 71205-883 | Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Proficient Rx LP | ANDA | Current |
| 71205-884 | Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Proficient Rx LP | ANDA | Current |
| 71205-884 | Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Proficient Rx LP | ANDA | Current |
| 71335-1606 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 71335-1606 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 71335-1785 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 71335-1833 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 71335-1834 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 71335-1835 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 71610-672 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 72189-219 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | direct rx | ANDA | Current |
| 72189-219 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | direct rx | ANDA | Current |
| 72189-219 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | direct rx | ANDA | Current |
| 72189-219 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | direct rx | ANDA | Current |
| 72189-219 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | direct rx | ANDA | Current |
| 72189-219 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | direct rx | ANDA | Current |
| 72189-219 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | direct rx | ANDA | Current |
| 72189-219 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | direct rx | ANDA | Current |
| 72189-220 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | direct rx | ANDA | Current |
| 72189-220 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | direct rx | ANDA | Current |
| 72189-220 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | direct rx | ANDA | Current |
| 72189-220 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | direct rx | ANDA | Current |
| 72189-220 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | direct rx | ANDA | Current |
| 72189-220 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | direct rx | ANDA | Current |
| 72189-220 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | direct rx | ANDA | Current |
| 72189-221 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | direct rx | ANDA | Current |
| 72189-221 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | direct rx | ANDA | Current |
| 72189-221 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | direct rx | ANDA | Current |
| 72189-221 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | direct rx | ANDA | Current |
| 72189-221 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | direct rx | ANDA | Current |