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 | Solco Healthcare US, LLC. | 1016cad7-2198-483c-893b-e25fd397a226 | 2022-05-31 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Proficient Rx LP | d51f3618-4166-4925-8994-968a653ebc46 | 2022-05-02 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Proficient Rx LP | d80aa4af-a8ce-4cae-b71c-05e1de829551 | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Proficient Rx LP | 5f243894-bda3-4fa9-97e4-209dcb389dee | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS | ScieGen Pharmaceuticals, Inc. | 16dc4008-7b5e-4c6d-9bc8-8db96be911a1 | 2022-03-21 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Proficient Rx LP | 738402d6-3700-46b2-a90c-2e8f2c354a39 | 2022-03-01 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin hydrochloride | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | c789254c-be70-4d25-8c6c-b284b01eb513 | 2022-02-22 | Boxed warning, Adverse reactions | Metformin hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin hydrochloride | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 5e5fb10b-b874-43c9-9424-9080b9e866c8 | 2022-02-22 | Boxed warning, Adverse reactions | Metformin hydrochloride METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE EXTENDED RELEASE | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 0b843f12-a654-4751-be1f-55e6fce163c9 | 2021-12-08 | Warnings | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 1e298db3-439e-4e91-8f9e-01c3cdc4d552 | 2021-08-02 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 4d89a4ab-6cdd-4c39-92f9-a137fa27a070 | 2021-07-02 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS | ScieGen Pharmaceuticals, Inc. | 1452fbb1-e591-4a51-9f83-8a8a6a780b52 | 2021-06-28 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 439bb230-94d8-4522-ad79-5cce5fad965b | 2021-04-27 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | 9632456f-57c2-444b-9f43-d9ca862681fe | 2021-03-10 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | ACI Healthcare USA, Inc. | e18b60f9-721e-4db6-9f61-d3437e18faf2 | 2020-12-26 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Epic Pharma, LLC | 8c1848f9-c113-4552-b6ef-715e72630ad9 | 2019-11-04 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Proficient Rx LP | 6f6118c1-cecc-4d7b-9965-7b114a1ad56b | 2019-10-01 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | PuraCap Laboratories LLC dba Blu Pharmaceuticals | 5c2581e3-2b30-4da5-8bed-228173ca20d2 | 2019-01-04 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Riomet | METFORMIN HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | 05d4df4b-dfe8-4828-b423-a3d4f2c4114a | 2018-12-06 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Amneal Pharmaceuticals LLC | c01a79e0-f2b7-4d99-857e-bda7f24fe319 | 2018-08-30 | 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 |