Application 213962
- Type
- ANDA
- Sponsor
- AJANTA PHARMA LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 500MG | No | No |
| 002 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 1GM | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A213962-001 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-03-09 | |
| A213962-002 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | RS | 2021-03-09 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A213962-001 | AB3 |
| A213962-002 | AB3 |
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 | A213962-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-03-09 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A213962-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | RS | 2021-03-09 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A213962-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-03-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A213962-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | RS | 2021-03-09 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A213962-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-03-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213962-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | RS | 2021-03-09 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213962-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-03-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213962-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | RS | 2021-03-09 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A213962-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-03-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213962-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-03-09 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213962-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-03-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213962-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-03-09 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213962-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-03-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213962-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-03-09 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213962-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-03-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213962-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-03-09 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213962-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-03-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213962-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-03-09 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213962-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-03-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213962-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-03-09 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213962-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-03-09 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213962-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-03-09 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A213962-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-03-09 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A213962-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-03-09 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213962-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-03-09 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213962-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-03-09 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213962-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-03-09 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213962-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-03-09 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213962-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-03-09 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213962-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-03-09 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A213962-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-03-09 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A213962-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-03-09 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A213962-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-03-09 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A213962-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-03-09 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A213962-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-03-09 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A213962-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-03-09 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A213962-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-03-09 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A213962-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-03-09 | 4b0b4de00fa7… | |
| 2022-03-09 01:35 UTC | 2022-03 | A213962-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-03-09 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A213962-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-03-09 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A213962-001 | AB3 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A213962-002 | AB3 | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A213962-001 | AB3 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A213962-002 | AB3 | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A213962-001 | AB3 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A213962-002 | AB3 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213962-001 | AB3 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213962-002 | AB3 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A213962-001 | AB3 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A213962-002 | AB3 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213962-001 | AB3 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213962-002 | AB3 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213962-001 | AB3 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213962-002 | AB3 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213962-001 | AB3 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213962-002 | AB3 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213962-001 | AB3 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213962-002 | AB3 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213962-001 | AB3 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213962-002 | AB3 | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213962-001 | AB3 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213962-002 | AB3 | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A213962-001 | AB3 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A213962-002 | AB3 | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213962-001 | AB3 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213962-002 | AB3 | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213962-001 | AB3 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213962-002 | AB3 | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213962-001 | AB3 | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213962-002 | AB3 | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A213962-001 | AB3 | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A213962-002 | AB3 | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A213962-001 | AB3 | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A213962-002 | AB3 | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A213962-001 | AB3 | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A213962-002 | AB3 | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A213962-001 | AB3 | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A213962-002 | AB3 | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | A213962-001 | AB3 | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A213962-002 | AB3 | 1 | bb7c543d1eb4… |
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 | 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 | Preferred Pharmaceuticals Inc. | 5073c482-952c-400c-afff-64380f133bc8 | 2026-01-16 | 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 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Northwind Health Company, LLC | 0178b9dd-bafa-9e81-e063-6294a90a88b0 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Northwind Health Company, LLC | f5ef117c-27ff-c21e-e053-2995a90ae145 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Northwind Health Company, LLC | db113f46-6fac-9005-e053-2995a90a017a | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE EXTENDED RELEASE | METFORMIN HYDROCHLORIDE | Northwind Health Company, LLC | 4e5a19c6-6ac6-ffc0-e063-6394a90a9827 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Micro Labs Limited | cc070735-5e8d-4bb3-9caa-e84d29bb8943 | 2025-12-21 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Ascend Laboratories, LLC | 0ff1ba75-3c86-4baf-a6b1-1bb883839866 | 2025-12-18 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | b63bfafa-db4c-4fb8-84cd-ff73a5e7d320 | 2025-12-17 | 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 |
|---|---|---|---|---|---|
| 27241-240 | Metformin hydrochloride | Metformin hydrochloride | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-240 | Metformin hydrochloride | Metformin hydrochloride | Ajanta Pharma Limited | ANDA | Current |
| 27241-241 | Metformin hydrochloride | Metformin hydrochloride | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-241 | Metformin hydrochloride | Metformin hydrochloride | Ajanta Pharma Limited | ANDA | Current |