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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 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… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090564-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-04-22 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090564-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | RS | 2010-04-22 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090564-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-04-22 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 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… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090564-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090564-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090564-001 | AB | 1 | 301d65b070ca… |
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 HCl | METFORMIN HCL | Unit Dose Solutions, Inc. | 5538e9df-0983-9281-e063-6394a90a9249 | 2026-08-18 | Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | 1e8136e0-cc98-41e4-ad4b-a8fc27fb4daa | 2026-08-04 | Boxed warning, Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin HCl | METFORMIN HCL | PD-Rx Pharmaceuticals, Inc. | c8e50300-1838-4c51-8d9d-ebbaaf0f3991 | 2026-08-03 | Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | 59a4ccda-5487-4ac4-9373-0c0fc8b7c88b | 2026-08-03 | Boxed warning, Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | 30658e19-8e6e-49aa-a007-e414224797c5 | 2026-07-29 | Boxed warning, Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Cardinal Health 107, LLC | 46cb7e3f-c739-433d-9dbe-427c2d95bef1 | 2026-07-24 | Boxed warning, Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | 5aa1c86c-f2c8-49b1-8f81-47b11386c5d3 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin HCl | METFORMIN HCL | PD-Rx Pharmaceuticals, Inc. | fb890205-5d43-41eb-97b2-fb0dcdd3a950 | 2026-07-13 | Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE TABLET | Granules India Ltd | 8cd5555c-f6b2-28d8-e053-2a95a90a5f1e | 2026-06-29 | Boxed warning, Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Unit Dose Solutions, Inc. | 552ad61d-bafd-478d-e063-6294a90a02f9 | 2026-06-26 | Boxed warning, Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin HCl | METFORMIN HCL | Unit Dose Solutions, Inc. | 552df462-6dcb-e6f2-e063-6294a90aacfe | 2026-06-26 | Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Major Pharmaceuticals | 5e783025-bf6d-465e-bf58-bcd253afad2c | 2026-06-24 | Boxed warning, Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 62ca8af4-ff91-4bf6-b7c6-895b3b5ce8c3 | 2026-06-19 | Boxed warning, Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 902d1bc4-3f1f-4a1a-86d7-cf98c56a3684 | 2026-06-19 | Boxed warning, Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 33550b88-d4bb-4ce6-a7db-07c966f6984f | 2026-06-19 | Boxed warning, Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Coupler LLC | 53e950f5-c58f-78e3-e063-6294a90a53e9 | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin HCl | METFORMIN HCL | Proficient Rx LP | d2c927eb-12bf-4c7d-9ef5-0036b2dd8c29 | 2026-06-01 | Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin HCl | METFORMIN HCL | Northwind Health Company, LLC | 13b1e35f-d047-8ddc-e063-6394a90a24dd | 2026-05-14 | Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Coupler LLC | 51285096-e2ce-0f3c-e063-6394a90a35d4 | 2026-05-06 | Boxed warning, Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Granules Pharmaceuticals Inc. | 2387a618-24d8-4813-aa83-9114edb35374 | 2026-04-16 | Boxed warning, 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 |
|---|---|---|---|---|---|
| 63187-101 | Metformin Hydrochloride | Metformin Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-101 | Metformin Hydrochloride | Metformin Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-102 | Metformin Hydrochloride | Metformin Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-102 | Metformin Hydrochloride | Metformin Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63629-1395 | Metformin Hydrochloride | Metformin hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-1395 | Metformin Hydrochloride | Metformin hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-7694 | Metformin HCl | Metformin HCl | Bryant Ranch Prepack | ANDA | Current |
| 63629-7694 | Metformin HCl | Metformin HCl | Bryant Ranch Prepack | ANDA | Current |
| 63629-7925 | metformin hydrochloride | metformin hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-8093 | metformin hydrochloride | metformin hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-8093 | metformin hydrochloride | metformin hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-8094 | metformin hydrochloride | metformin hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-8094 | metformin hydrochloride | metformin hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 64725-0102 | Metformin Hydrochloride | Metformin Hydrochloride | TYA Pharmaceuticals | ANDA | Current |
| 66267-497 | Metformin hydrochloride | Metformin hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 66267-497 | Metformin hydrochloride | Metformin hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 66267-553 | Metformin hydrochloride | Metformin hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 66267-553 | Metformin hydrochloride | Metformin hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 67046-459 | Metformin hydrochloride | Metformin hydrochloride | Contract Pharmacy Services-PA | ANDA | Current |
| 67046-463 | Metformin hydrochloride | Metformin hydrochloride | Contract Pharmacy Services-PA | ANDA | Current |
| 67046-464 | Metformin hydrochloride | Metformin hydrochloride | Contract Pharmacy Services-PA | ANDA | Current |
| 67296-0893 | metformin hydrochloride | metformin hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1604 | Metformin HCl | Metformin HCl | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1604 | Metformin HCl | Metformin HCl | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1604 | Metformin HCl | Metformin HCl | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1744 | metformin hydrochloride | metformin hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 67877-561 | Metformin HCl | Metformin HCl | Ascend Laboratories, LLC | ANDA | Current |
| 67877-562 | Metformin HCl | Metformin HCl | Ascend Laboratories, LLC | ANDA | Current |
| 67877-563 | Metformin HCl | Metformin HCl | Ascend Laboratories, LLC | ANDA | Current |
| 68071-1774 | Metformin hydrochloride | Metformin hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-1774 | Metformin hydrochloride | Metformin hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-1781 | Metformin hydrochloride | Metformin hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-1781 | Metformin hydrochloride | Metformin hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-1815 | Metformin hydrochloride | Metformin hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-1815 | Metformin hydrochloride | Metformin hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-3117 | Metformin hydrochloride | Metformin hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3117 | Metformin hydrochloride | Metformin hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3126 | Metformin hydrochloride | Metformin hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3126 | Metformin hydrochloride | Metformin hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3200 | Metformin hydrochloride | Metformin hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3200 | Metformin hydrochloride | Metformin hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-4420 | Metformin HCl | Metformin HCl | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4420 | Metformin HCl | Metformin HCl | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4525 | Metformin hydrochloride | Metformin hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4525 | Metformin hydrochloride | Metformin hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4525 | Metformin hydrochloride | Metformin hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4560 | Metformin hydrochloride | Metformin hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4560 | Metformin hydrochloride | Metformin hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4605 | Metformin hydrochloride | Metformin hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4605 | Metformin Hydrochloride | Metformin Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4605 | Metformin Hydrochloride | Metformin Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4669 | Metformin hydrochloride | Metformin hydrochloride | NuCare Pharmaceuticals,In | ANDA | Current |
| 68071-4669 | Metformin hydrochloride | Metformin hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4669 | Metformin hydrochloride | Metformin hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4669 | Metformin hydrochloride | Metformin hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4670 | Metformin hydrochloride | Metformin hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4670 | Metformin hydrochloride | Metformin hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4683 | Metformin hydrochloride | Metformin hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4683 | Metformin hydrochloride | Metformin hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4804 | metformin hydrochloride | metformin hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4804 | metformin hydrochloride | metformin hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5031 | metformin hydrochloride | metformin hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5031 | metformin hydrochloride | metformin hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5051 | metformin hydrochloride | metformin hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5051 | metformin hydrochloride | metformin hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5131 | metformin hydrochloride | metformin hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5131 | metformin hydrochloride | metformin hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68151-1442 | Metformin Hydrochloride | Metformin Hydrochloride | Carilion Materials Management | ANDA | Current |
| 68645-544 | Metformin hydrochloride | Metformin hydrochloride | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-544 | Metformin hydrochloride | Metformin hydrochloride | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-544 | Metformin hydrochloride | Metformin hydrochloride | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-544 | Metformin hydrochloride | Metformin hydrochloride | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-544 | Metformin hydrochloride | Metformin hydrochloride | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-545 | Metformin hydrochloride | Metformin hydrochloride | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-545 | Metformin hydrochloride | Metformin hydrochloride | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-545 | Metformin hydrochloride | Metformin hydrochloride | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-545 | Metformin hydrochloride | Metformin hydrochloride | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-545 | Metformin hydrochloride | Metformin hydrochloride | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-546 | Metformin hydrochloride | Metformin hydrochloride | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-546 | Metformin hydrochloride | Metformin hydrochloride | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |