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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 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… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203769-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2013-09-11 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203769-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2013-09-11 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203769-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2013-09-11 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203769-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2013-09-11 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203769-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2013-09-11 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 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… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203769-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203769-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203769-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203769-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A203769-001 | AB | 1 | d06236e962d9… |
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 | ScieGen Pharmaceuticals Inc | 4e4c4ba9-65c6-4273-8f6b-2423ab521dad | 2026-08-21 | Boxed warning, Warnings, Adverse reactions | 203769 ANDA203769 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | 13235d8e-ac3a-45b4-9c5d-9a9012951dfe | 2026-07-16 | Boxed warning, Warnings, Adverse reactions | 203769 ANDA203769 70518-1951 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Westminster Pharmaceuticals, LLC | 836f3647-bfef-40d1-b475-c0d240241a67 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | 203769 ANDA203769 69367-182 69367-180 69367-181 |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 388ee1e0-a0d2-324d-e063-6394a90a1664 | 2026-03-25 | Boxed warning, Warnings, Adverse reactions | 203769 ANDA203769 |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | direct rx | c33e24e9-0441-6b94-e053-2a95a90a9c68 | 2026-03-05 | Boxed warning, Warnings, Adverse reactions | 203769 ANDA203769 72189-220 72189-219 72189-221 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Method Pharmaceuticals, LLC. | 4aa880a4-7ec0-9155-e063-6394a90a8f3e | 2026-02-09 | Boxed warning, Warnings, Adverse reactions | 203769 ANDA203769 |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc | dfac4d9c-2f20-417c-a1be-4f1c2738f351 | 2026-01-27 | Boxed warning, Warnings, Adverse reactions | 203769 ANDA203769 |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 273d86b0-9d30-48c9-8918-c5e1ececa951 | 2026-01-22 | Boxed warning, Warnings, Adverse reactions | 203769 ANDA203769 |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | 72dbc087-9a84-4126-bf54-c5254a8b129c | 2025-07-09 | Boxed warning, Warnings, Adverse reactions | 203769 ANDA203769 |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 3982b985-9184-0e17-e063-6394a90aae05 | 2025-07-09 | Boxed warning, Warnings, Adverse reactions | 203769 ANDA203769 |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 3890b116-7c3c-e48e-e063-6294a90a0c8a | 2025-07-03 | Boxed warning, Warnings, Adverse reactions | 203769 ANDA203769 |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | ec3a9070-3745-41fb-b610-8d06129d8fd9 | 2025-07-01 | Boxed warning, Warnings, Adverse reactions | 203769 ANDA203769 |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | 51e1fe6e-a7fa-47a5-bbd5-73b275230c7f | 2025-07-01 | Boxed warning, Warnings, Adverse reactions | 203769 ANDA203769 |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | 32d6c5f4-0116-4e38-b179-e1967ae63e66 | 2024-08-08 | Boxed warning, Warnings, Adverse reactions | 203769 ANDA203769 71335-1834 |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | 4670d280-53c3-4c51-b3c5-26d71e47bddc | 2024-08-08 | Boxed warning, Warnings, Adverse reactions | 203769 ANDA203769 71335-1833 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Proficient Rx LP | 928ef685-80cb-42a9-a155-3c21c9b1dd67 | 2024-03-01 | Boxed warning, Warnings, Adverse reactions | 203769 ANDA203769 |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | 9c33414b-5dbb-4ce9-910b-9480d45e50ee | 2024-02-05 | Boxed warning, Warnings, Adverse reactions | 203769 ANDA203769 |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | f9e78e0f-6a0a-4db3-bc09-5500748f9c84 | 2024-02-05 | Boxed warning, Warnings, Adverse reactions | 203769 ANDA203769 |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | 88af3365-1145-45a1-ab0f-1c794f0c13db | 2023-05-24 | Boxed warning, Warnings, Adverse reactions | 203769 ANDA203769 71335-1835 |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | 8ce6b615-2abd-4a5b-997b-11aa1aec142d | 2023-03-28 | Boxed warning, Warnings, Adverse reactions | 203769 ANDA203769 |
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 |