Application 091184
- Type
- ANDA
- Sponsor
- ALKEM
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 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A091184-001 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-11-01 | |
| A091184-002 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-11-01 | |
| A091184-003 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2010-11-01 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A091184-001 | AB |
| A091184-002 | AB |
| A091184-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-11-14 07:37:17 | 2026-10 | A091184-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-11-01 | d4dbc9d85df4… | |
| 2026-11-14 07:37:17 | 2026-10 | A091184-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-11-01 | d4dbc9d85df4… | |
| 2026-11-14 07:37:17 | 2026-10 | A091184-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2010-11-01 | d4dbc9d85df4… | |
| 2026-10-15 13:18:30 | 2026-09 | A091184-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-11-01 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A091184-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-11-01 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A091184-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2010-11-01 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A091184-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-11-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A091184-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-11-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A091184-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2010-11-01 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A091184-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-11-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A091184-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-11-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A091184-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2010-11-01 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091184-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-11-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091184-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-11-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091184-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2010-11-01 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091184-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-11-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091184-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-11-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091184-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2010-11-01 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091184-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-11-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091184-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-11-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091184-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2010-11-01 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091184-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-11-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091184-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-11-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091184-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2010-11-01 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091184-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-11-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091184-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-11-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091184-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2010-11-01 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091184-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-11-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091184-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-11-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091184-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2010-11-01 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091184-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-11-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091184-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-11-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091184-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2010-11-01 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091184-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-11-01 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091184-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-11-01 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091184-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2010-11-01 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091184-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-11-01 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091184-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-11-01 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091184-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2010-11-01 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091184-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-11-01 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-11-14 07:37:17 | 2026-10 | A091184-001 | AB | 1 | d4dbc9d85df4… |
| 2026-11-14 07:37:17 | 2026-10 | A091184-002 | AB | 1 | d4dbc9d85df4… |
| 2026-11-14 07:37:17 | 2026-10 | A091184-003 | AB | 1 | d4dbc9d85df4… |
| 2026-10-15 13:18:30 | 2026-09 | A091184-001 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A091184-002 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A091184-003 | AB | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A091184-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A091184-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A091184-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A091184-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A091184-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A091184-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A091184-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091184-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091184-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091184-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091184-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091184-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A091184-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091184-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091184-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091184-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091184-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091184-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091184-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091184-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091184-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091184-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091184-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091184-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091184-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091184-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091184-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091184-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091184-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091184-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091184-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091184-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091184-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A091184-001 | 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 | A-S Medication Solutions | 239834b0-121a-4903-b3ee-90bb4db4753b | 2026-02-04 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | 5f2023d2-05ae-489d-9e18-fb75057496bc | 2026-02-04 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | 1d7556eb-82b4-4085-b0b1-dc061b216feb | 2026-02-02 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Quallent Pharmaceuticals Health LLC | 6864ff5a-7512-4a4f-ad26-b2b9c5843414 | 2026-01-30 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | 8c248958-6c01-455e-89f5-959facb272ed | 2026-01-29 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | 192970d3-826a-4b69-a525-9742794dc19c | 2026-01-28 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc | dfac4d9c-2f20-417c-a1be-4f1c2738f351 | 2026-01-27 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 273d86b0-9d30-48c9-8918-c5e1ececa951 | 2026-01-22 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 64650d2c-2bec-4470-b250-29d01caa1ebe | 2026-01-20 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | ca71c133-6c38-4b9e-80af-1949634157f4 | 2026-01-19 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| metformin hydrochloride | METFORMIN HYDROCHLORIDE TABLETS | EPIC PHARMA, LLC | 356b02d0-d239-4441-bb33-c4c54166fcd7 | 2026-01-15 | Boxed warning, Warnings, Adverse reactions | metformin hydrochloride |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | e3e9b582-fd15-4fe0-a210-398d9149696e | 2026-01-12 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | AvPAK | d9bac244-1725-5bf3-e053-2a95a90ac823 | 2026-01-08 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | AvPAK | de09f7a1-1e9f-60f4-e053-2a95a90a93d8 | 2026-01-08 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin hydrochloride | METFORMIN HYDROCHLORIDE | Proficient Rx LP | 3ba957ea-28ed-4a61-a318-98064ea4944d | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | Metformin hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Northwind Health Company, LLC | ab80521b-5014-cc2a-e053-2a95a90a2003 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Northwind Health Company, LLC | f31c08fc-cda1-349c-e053-2a95a90aba15 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Northwind Health Company, LLC | dae7b1c1-7ff1-883c-e053-2a95a90a1a2b | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Northwind Health Company, LLC | f2a27d7a-ade4-421f-e053-2a95a90a01a9 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Northwind Health Company, LLC | 07d8a69f-30d9-7511-e063-6394a90a95ca | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
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 |
|---|---|---|---|---|---|
| 0440-5739 | Metformin Hydrochloride | Metformin Hydrochloride | Liberty Pharmaceuticals, Inc. | ANDA | Current |
| 0440-5745 | Metformin Hydrochloride | Metformin Hydrochloride | Liberty Pharmaceuticals, Inc. | ANDA | Current |
| 0440-5746 | Metformin Hydrochloride | Metformin Hydrochloride | Liberty Pharmaceuticals, Inc. | ANDA | Current |
| 0904-6326 | Metformin Hydrochloride | Metformin Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6327 | Metformin Hydrochloride | Metformin Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6328 | Metformin Hydrochloride | Metformin Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 12634-756 | Metformin Hydrochloride | Metformin Hydrochloride | Apotheca Inc. | ANDA | Current |
| 12634-757 | Metformin Hydrochloride | Metformin Hydrochloride | Apotheca Inc. | ANDA | Current |
| 12634-789 | Metformin Hydrochloride | Metformin Hydrochloride | Apotheca Inc. | ANDA | Current |
| 42708-117 | Metformin Hydrochloride | Metformin Hydrochloride | QPharma Inc | ANDA | Current |
| 42708-117 | Metformin Hydrochloride | Metformin Hydrochloride | QPharma Inc | ANDA | Current |
| 43353-128 | Metformin Hydrochloride | Metformin Hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 50090-2410 | Metformin Hydrochloride | Metformin Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2612 | Metformin Hydrochloride | Metformin Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2635 | Metformin Hydrochloride | Metformin Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3088 | Metformin Hydrochloride | Metformin Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 53808-1033 | Metformin Hydrochloride | Metformin Hydrochloride | State of Florida DOH Central Pharmacy | ANDA | Current |
| 55154-5888 | Metformin Hydrochloride | Metformin Hydrochloride | Cardinal Health | ANDA | Current |
| 55154-5888 | Metformin Hydrochloride | Metformin Hydrochloride | Cardinal Health | ANDA | Current |
| 55700-475 | Metformin Hydrochloride | Metformin Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 67877-217 | Metformin Hydrochloride | Metformin Hydrochloride | Ascend Laboratories, LLC | ANDA | Current |
| 67877-217 | Metformin Hydrochloride | Metformin Hydrochloride | Ascend Laboratories, LLC | ANDA | Current |
| 67877-217 | Metformin Hydrochloride | Metformin Hydrochloride | Ascend Laboratories, LLC | ANDA | Current |
| 67877-218 | Metformin Hydrochloride | Metformin Hydrochloride | Ascend Laboratories, LLC | ANDA | Current |
| 67877-218 | Metformin Hydrochloride | Metformin Hydrochloride | Ascend Laboratories, LLC | ANDA | Current |
| 67877-218 | Metformin Hydrochloride | Metformin Hydrochloride | Ascend Laboratories, LLC | ANDA | Current |
| 67877-221 | Metformin Hydrochloride | Metformin Hydrochloride | Ascend Laboratories, LLC | ANDA | Current |
| 67877-221 | Metformin Hydrochloride | Metformin Hydrochloride | Ascend Laboratories, LLC | ANDA | Current |
| 67877-221 | Metformin Hydrochloride | Metformin Hydrochloride | Ascend Laboratories, LLC | ANDA | Current |
| 68788-6982 | Metformin Hydrochloride | Metformin Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6982 | Metformin Hydrochloride | Metformin Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6982 | Metformin Hydrochloride | Metformin Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7069 | Metformin Hydrochloride | Metformin Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7069 | Metformin Hydrochloride | Metformin Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7069 | Metformin Hydrochloride | Metformin Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-0672 | Metformin Hydrochloride | Metformin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70882-125 | Metformin Hydrochloride | Metformin Hydrochloride | Cambridge Therapeutics Technologies, LLC | ANDA | Current |