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 EXTENDED RELEASE | METFORMIN HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 4a53ea53-3052-614b-e054-00144ff8d46c | 2024-07-19 | Warnings | METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Granules Pharmaceuticals Inc. | a5980bc8-8de8-c456-e053-2a95a90a792e | 2024-07-03 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | 1ef6c527-89f5-4830-8900-7532b0a7ef26 | 2024-06-25 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Epic Pharma, LLC | a9e7608f-540c-d90c-e053-2a95a90a4f98 | 2024-06-20 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 1a047fc0-196e-79af-e063-6394a90a1e0d | 2024-06-03 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | 1c046303-993c-4111-ac9a-40a0d97ca6a2 | 2024-04-30 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | 1a7f7ef3-a94b-4ff6-a9f2-f5de4a99c7f6 | 2024-04-28 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | afb183f6-a13c-4f00-82d5-9fe336173d34 | 2024-04-28 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | d5dbf0d9-9673-4aae-9e28-da9b90bac038 | 2024-03-11 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | c2783b59-7b20-4d4c-a3ca-03ed60dcf2c3 | 2024-03-10 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | 2be73d5e-7682-4ad3-831b-8c1ea73e38de | 2024-03-10 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Proficient Rx LP | 928ef685-80cb-42a9-a155-3c21c9b1dd67 | 2024-03-01 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 1182bf60-3578-a0ed-e063-6394a90aa50f | 2024-02-16 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | 9c33414b-5dbb-4ce9-910b-9480d45e50ee | 2024-02-05 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | f9e78e0f-6a0a-4db3-bc09-5500748f9c84 | 2024-02-05 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | 3c607f04-d36f-4cf8-9cc9-7f2af08b4098 | 2024-01-18 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | 7cc82387-8bb0-4bee-9967-cb13eab1d801 | 2024-01-08 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Amneal Pharmaceuticals of New York LLC | b090b18b-b53c-4c92-892f-d11551cfedc3 | 2023-12-14 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 38687872-ca68-4965-b317-637c25ba041e | 2023-11-09 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | d0bc43a4-301f-4002-9b58-bd81dddf2790 | 2023-10-20 | 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 |