Application 212595
- Type
- NDA
- Sponsor
- SUN PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RIOMET ER | METFORMIN HYDROCHLORIDE | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 500MG/5ML | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N212595-001 | RIOMET ER | METFORMIN HYDROCHLORIDE | 500MG/5ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2019-08-29 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N212595-001 | 9962336 | 2035-05-01 | Drug product | 2019-09-05 |
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 | N212595-001 | RIOMET ER | 500MG/5ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2019-08-29 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N212595-001 | RIOMET ER | 500MG/5ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2019-08-29 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N212595-001 | RIOMET ER | 500MG/5ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2019-08-29 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N212595-001 | RIOMET ER | 500MG/5ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2019-08-29 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N212595-001 | RIOMET ER | 500MG/5ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2019-08-29 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N212595-001 | RIOMET ER | 500MG/5ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2019-08-29 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N212595-001 | RIOMET ER | 500MG/5ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2019-08-29 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N212595-001 | RIOMET ER | 500MG/5ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2019-08-29 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N212595-001 | RIOMET ER | 500MG/5ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2019-08-29 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N212595-001 | RIOMET ER | 500MG/5ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2019-08-29 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N212595-001 | RIOMET ER | 500MG/5ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2019-08-29 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N212595-001 | RIOMET ER | 500MG/5ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2019-08-29 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N212595-001 | RIOMET ER | 500MG/5ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2019-08-29 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N212595-001 | RIOMET ER | 500MG/5ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2019-08-29 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N212595-001 | RIOMET ER | 500MG/5ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2019-08-29 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N212595-001 | RIOMET ER | 500MG/5ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2019-08-29 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N212595-001 | RIOMET ER | 500MG/5ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2019-08-29 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N212595-001 | RIOMET ER | 500MG/5ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2019-08-29 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N212595-001 | RIOMET ER | 500MG/5ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2019-08-29 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N212595-001 | RIOMET ER | 500MG/5ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2019-08-29 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N212595-001 | RIOMET ER | 500MG/5ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2019-08-29 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N212595-001 | RIOMET ER | 500MG/5ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2019-08-29 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N212595-001 | RIOMET ER | 500MG/5ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2019-08-29 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N212595-001 | RIOMET ER | 500MG/5ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2019-08-29 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N212595-001 | RIOMET ER | 500MG/5ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2019-08-29 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N212595-001 | RIOMET ER | 500MG/5ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2019-08-29 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N212595-001 | RIOMET ER | 500MG/5ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2019-08-29 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N212595-001 | RIOMET ER | 500MG/5ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2019-08-29 | b00525d2431f… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N212595-001 | RIOMET ER | 500MG/5ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2019-08-29 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N212595-001 | RIOMET ER | 500MG/5ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2019-08-29 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N212595-001 | RIOMET ER | 500MG/5ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2019-08-29 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N212595-001 | RIOMET ER | 500MG/5ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2019-08-29 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N212595-001 | RIOMET ER | 500MG/5ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2019-08-29 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N212595-001 | RIOMET ER | 500MG/5ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2019-08-29 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N212595-001 | RIOMET ER | 500MG/5ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2019-08-29 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N212595-001 | RIOMET ER | 500MG/5ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2019-08-29 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N212595-001 | RIOMET ER | 500MG/5ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2019-08-29 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N212595-001 | RIOMET ER | 500MG/5ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2019-08-29 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N212595-001 | RIOMET ER | 500MG/5ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2019-08-29 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N212595-001 | RIOMET ER | 500MG/5ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2019-08-29 | e64feba35796… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N212595-001 | 9962336 | 2035-05-01 | Drug product | 2019-09-05 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N212595-001 | 9962336 | 2035-05-01 | Drug product | 2019-09-05 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N212595-001 | 9962336 | 2035-05-01 | Drug product | 2019-09-05 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N212595-001 | 9962336 | 2035-05-01 | Drug product | 2019-09-05 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N212595-001 | 9962336 | 2035-05-01 | Drug product | 2019-09-05 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N212595-001 | 9962336 | 2035-05-01 | Drug product | 2019-09-05 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N212595-001 | 9962336 | 2035-05-01 | Drug product | 2019-09-05 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N212595-001 | 9962336 | 2035-05-01 | Drug product | 2019-09-05 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N212595-001 | 9962336 | 2035-05-01 | Drug product | 2019-09-05 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N212595-001 | 9962336 | 2035-05-01 | Drug product | 2019-09-05 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N212595-001 | 9962336 | 2035-05-01 | Drug product | 2019-09-05 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N212595-001 | 9962336 | 2035-05-01 | Drug product | 2019-09-05 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N212595-001 | 9962336 | 2035-05-01 | Drug product | 2019-09-05 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N212595-001 | 9962336 | 2035-05-01 | Drug product | 2019-09-05 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N212595-001 | 9962336 | 2035-05-01 | Drug product | 2019-09-05 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N212595-001 | 9962336 | 2035-05-01 | Drug product | 2019-09-05 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N212595-001 | 9962336 | 2035-05-01 | Drug product | 2019-09-05 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N212595-001 | 9962336 | 2035-05-01 | Drug product | 2019-09-05 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N212595-001 | 9962336 | 2035-05-01 | Drug product | 2019-09-05 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N212595-001 | 9962336 | 2035-05-01 | Drug product | 2019-09-05 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N212595-001 | 9962336 | 2035-05-01 | Drug product | 2019-09-05 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N212595-001 | 9962336 | 2035-05-01 | Drug product | 2019-09-05 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N212595-001 | 9962336 | 2035-05-01 | Drug product | 2019-09-05 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N212595-001 | 9962336 | 2035-05-01 | Drug product | 2019-09-05 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N212595-001 | 9962336 | 2035-05-01 | Drug product | 2019-09-05 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N212595-001 | 9962336 | 2035-05-01 | Drug product | 2019-09-05 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N212595-001 | 9962336 | 2035-05-01 | Drug product | 2019-09-05 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N212595-001 | 9962336 | 2035-05-01 | Drug product | 2019-09-05 | b00525d2431f… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N212595-001 | 9962336 | 2035-05-01 | Drug product | 2019-09-05 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N212595-001 | 9962336 | 2035-05-01 | Drug product | 2019-09-05 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N212595-001 | 9962336 | 2035-05-01 | Drug product | 2019-09-05 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N212595-001 | 9962336 | 2035-05-01 | Drug product | 2019-09-05 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N212595-001 | 9962336 | 2035-05-01 | Drug product | 2019-09-05 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N212595-001 | 9962336 | 2035-05-01 | Drug product | 2019-09-05 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N212595-001 | 9962336 | 2035-05-01 | Drug product | 2019-09-05 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N212595-001 | 9962336 | 2035-05-01 | Drug product | 2019-09-05 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N212595-001 | 9962336 | 2035-05-01 | Drug product | 2019-09-05 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N212595-001 | 9962336 | 2035-05-01 | Drug product | 2019-09-05 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N212595-001 | 9962336 | 2035-05-01 | Drug product | 2019-09-05 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N212595-001 | 9962336 | 2035-05-01 | Drug product | 2019-09-05 | e64feba35796… |
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 | NuCare Pharmaceuticals, Inc. | 403349a1-ec19-8982-e063-6294a90aa060 | 2025-10-02 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin hydrochloride | METFORMIN HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 4be72741-4f6d-6689-e054-00144ff8d46c | 2025-09-22 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Coupler LLC | 3eeee3b7-188a-05a0-e063-6294a90a1853 | 2025-09-16 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Ascend Laboratories, LLC | 8c7835fa-3f68-4850-b1da-34893bafb485 | 2025-08-28 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 3d450933-8d9d-27de-e063-6294a90ae6d9 | 2025-08-26 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | f2318509-9a49-4c99-a08b-22381f17aacd | 2025-08-25 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 3cbb802d-d493-255e-e063-6294a90a32f2 | 2025-08-19 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | 53ba7031-be87-47a5-ade7-494c6c489cc6 | 2025-08-18 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | 056072d8-6228-4914-831d-ee7c0661b742 | 2025-08-18 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | e1ebb146-acfd-4301-a79c-f5bb243f8575 | 2025-08-06 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | bf918d78-3fb6-4d8d-b42d-538ea10bc3e4 | 2025-08-06 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | e55ee270-5eb9-4848-8529-9af2a79669c0 | 2025-07-31 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 3ab4efb6-bd30-2583-e063-6294a90a415b | 2025-07-24 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | 72dbc087-9a84-4126-bf54-c5254a8b129c | 2025-07-09 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 3982b985-9184-0e17-e063-6394a90aae05 | 2025-07-09 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | bb62088f-e9af-4644-9f57-cb90bab0f199 | 2025-07-09 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | 59743092-bae1-4725-ac4b-c8a8b0a81c1e | 2025-07-09 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 3890b116-7c3c-e48e-e063-6294a90a0c8a | 2025-07-03 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 390c3bdf-bfaf-203e-e063-6394a90a7d20 | 2025-07-03 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | ec3a9070-3745-41fb-b610-8d06129d8fd9 | 2025-07-01 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.