Application 021748
- Type
- NDA
- Sponsor
- SANTARUS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GLUMETZA | METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 500MG | Yes | No |
| 002 | GLUMETZA | METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 1GM | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021748-001 | GLUMETZA | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-06-03 | |
| N021748-002 | GLUMETZA | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-06-03 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N021748-001 | GLUMETZA | 500MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-06-03 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N021748-002 | GLUMETZA | 1GM | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-06-03 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N021748-001 | GLUMETZA | 500MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-06-03 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021748-002 | GLUMETZA | 1GM | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-06-03 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N021748-001 | GLUMETZA | 500MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-06-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021748-002 | GLUMETZA | 1GM | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-06-03 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021748-001 | GLUMETZA | 500MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-06-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021748-002 | GLUMETZA | 1GM | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-06-03 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021748-001 | GLUMETZA | 500MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-06-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021748-002 | GLUMETZA | 1GM | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-06-03 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021748-001 | GLUMETZA | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | RLD | 2005-06-03 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021748-002 | GLUMETZA | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | RLD, RS | 2005-06-03 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021748-001 | GLUMETZA | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | RLD | 2005-06-03 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021748-002 | GLUMETZA | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | RLD, RS | 2005-06-03 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021748-001 | GLUMETZA | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | RLD | 2005-06-03 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021748-002 | GLUMETZA | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | RLD, RS | 2005-06-03 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021748-001 | GLUMETZA | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | RLD | 2005-06-03 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021748-002 | GLUMETZA | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | RLD, RS | 2005-06-03 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021748-001 | GLUMETZA | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | RLD | 2005-06-03 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021748-002 | GLUMETZA | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | RLD, RS | 2005-06-03 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021748-001 | GLUMETZA | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | RLD | 2005-06-03 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021748-002 | GLUMETZA | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | RLD, RS | 2005-06-03 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021748-001 | GLUMETZA | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | RLD | 2005-06-03 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021748-002 | GLUMETZA | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | RLD, RS | 2005-06-03 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021748-001 | GLUMETZA | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | RLD | 2005-06-03 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021748-002 | GLUMETZA | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | RLD, RS | 2005-06-03 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021748-001 | GLUMETZA | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | RLD | 2005-06-03 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021748-002 | GLUMETZA | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | RLD, RS | 2005-06-03 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021748-001 | GLUMETZA | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | RLD | 2005-06-03 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021748-002 | GLUMETZA | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | RLD, RS | 2005-06-03 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021748-001 | GLUMETZA | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | RLD | 2005-06-03 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021748-002 | GLUMETZA | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | RLD, RS | 2005-06-03 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N021748-001 | GLUMETZA | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | RLD | 2005-06-03 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N021748-002 | GLUMETZA | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | RLD, RS | 2005-06-03 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021748-001 | GLUMETZA | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | RLD | 2005-06-03 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021748-002 | GLUMETZA | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | RLD, RS | 2005-06-03 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N021748-001 | GLUMETZA | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | RLD | 2005-06-03 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N021748-002 | GLUMETZA | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | RLD, RS | 2005-06-03 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N021748-001 | GLUMETZA | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | RLD | 2005-06-03 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N021748-002 | GLUMETZA | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | RLD, RS | 2005-06-03 | 4b0b4de00fa7… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-08-23 18:47 UTC | 2025-08 | N021748-001 | AB3 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021748-002 | AB3 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021748-001 | AB3 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021748-002 | AB3 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021748-001 | AB3 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021748-002 | AB3 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021748-001 | AB3 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021748-002 | AB3 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021748-001 | AB3 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021748-002 | AB3 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021748-001 | AB3 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021748-002 | AB3 | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021748-001 | AB3 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021748-002 | AB3 | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021748-001 | AB3 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021748-002 | AB3 | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021748-001 | AB3 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021748-002 | AB3 | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021748-001 | AB3 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021748-002 | AB3 | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021748-001 | AB3 | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021748-002 | AB3 | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N021748-001 | AB3 | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N021748-002 | AB3 | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021748-001 | AB3 | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021748-002 | AB3 | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N021748-001 | AB3 | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N021748-002 | AB3 | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N021748-001 | AB3 | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N021748-002 | AB3 | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N021748-001 | AB3 | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021748-002 | AB3 | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N021748-001 | AB3 | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N021748-002 | AB3 | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N021748-001 | AB3 | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N021748-002 | AB3 | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021748-001 | AB3 | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021748-002 | AB3 | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N021748-001 | AB3 | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N021748-002 | AB3 | 1 | 5aa47cf7b7d7… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2020-11-12 02:37 UTC | 2020-11 | N021748-002 | 8323692 | 2023-03-30 | Drug product | 2012-12-12 | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | N021748-002 | 7780987 | 2025-03-23 | Drug substance, Drug product | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021748-001 | 6488962 | 2020-06-20 | Drug substance, Drug product | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021748-001 | 6723340 | 2021-10-25 | Drug substance, Drug product | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021748-002 | 8323692 | 2023-03-30 | Drug product | 2012-12-12 | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021748-002 | 7780987 | 2025-03-23 | Drug substance, Drug product | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021748-001 | 6488962 | 2020-06-20 | Drug substance, Drug product | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021748-001 | 6723340 | 2021-10-25 | Drug substance, Drug product | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021748-002 | 8323692 | 2023-03-30 | Drug product | 2012-12-12 | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N021748-002 | 7780987 | 2025-03-23 | Drug substance, Drug product | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021748-001 | 6488962 | 2020-06-20 | Drug substance, Drug product | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021748-001 | 6723340 | 2021-10-25 | Drug substance, Drug product | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021748-002 | 8323692 | 2023-03-30 | Drug product | 2012-12-12 | ea99ee380514… | |
| 2019-07-19 19:46 UTC | 2019-07 | N021748-002 | 7780987 | 2025-03-23 | Drug substance, Drug product | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N021748-002 | 7780987 | 2025-03-23 | Drug substance, Drug product | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N021748-002 | 7780987 | 2025-03-23 | Drug substance, Drug product | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N021748-002 | 8323692 | 2023-03-30 | Drug product | 2012-12-12 | ea1830bbd6c7… | |
| 2023-12-20 04:57 UTC | 2023-12 | N021748-002 | 7780987 | 2025-03-23 | Drug substance, Drug product | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N021748-002 | 8323692 | 2023-03-30 | Drug product | 2012-12-12 | a72a2bbeb626… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N021748-002 | 7780987 | 2025-03-23 | Drug substance, Drug product | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N021748-002 | 8323692 | 2023-03-30 | Drug product | 2012-12-12 | 9b2671bbb829… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N021748-002 | 7780987 | 2025-03-23 | Drug substance, Drug product | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N021748-002 | 8323692 | 2023-03-30 | Drug product | 2012-12-12 | a67488948f0b… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N021748-002 | 7780987 | 2025-03-23 | Drug substance, Drug product | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N021748-002 | 8323692 | 2023-03-30 | Drug product | 2012-12-12 | 3f0d92c62455… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N021748-002 | 7780987 | 2025-03-23 | Drug substance, Drug product | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N021748-002 | 8323692 | 2023-03-30 | Drug product | 2012-12-12 | 053a50430f4f… | |
| 2023-05-13 08:27 UTC | 2023-05 | N021748-002 | 7780987 | 2025-03-23 | Drug substance, Drug product | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N021748-002 | 8323692 | 2023-03-30 | Drug product | 2012-12-12 | 3bdfa0b2c4d7… | |
| 2023-01-26 05:58 UTC | 2023-01 | N021748-002 | 7780987 | 2025-03-23 | Drug substance, Drug product | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N021748-002 | 8323692 | 2023-03-30 | Drug product | 2012-12-12 | 3a93d1ddd44b… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N021748-002 | 7780987 | 2025-03-23 | Drug substance, Drug product | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N021748-002 | 8323692 | 2023-03-30 | Drug product | 2012-12-12 | f41ea6bd6efb… | |
| 2022-10-28 04:53 UTC | 2022-10 | N021748-002 | 7780987 | 2025-03-23 | Drug substance, Drug product | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N021748-002 | 8323692 | 2023-03-30 | Drug product | 2012-12-12 | e64feba35796… | |
| 2022-09-29 23:25 UTC | 2022-09 | N021748-002 | 7780987 | 2025-03-23 | Drug substance, Drug product | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N021748-002 | 8323692 | 2023-03-30 | Drug product | 2012-12-12 | cb3db0bc1861… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N021748-002 | 7780987 | 2025-03-23 | Drug substance, Drug product | cb3db0bc1861… |
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 | Oceanside Pharmaceuticals | 74d32a8a-c4c2-4dbb-b376-eea3f8fa64d7 | 2024-11-14 | Boxed warning, Warnings, Adverse reactions | 021748 NDA021748 68682-017 68682-021 68682-018 |
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 |
|---|---|---|---|---|---|
| 13913-002 | Glumetza | metformin hydrochloride | Depomed, Inc. | NDA | Current |
| 13913-003 | Glumetza | metformin hydrochloride | Depomed, Inc. | NDA | Current |
| 68012-002 | Glumetza | metformin hydrochloride | Santarus, Inc. | NDA | Current |
| 68012-002 | Glumetza | metformin hydrochloride | Santarus, Inc. | NDA | Current |
| 68012-002 | Glumetza | metformin hydrochloride | Santarus, Inc. | NDA | Current |
| 68012-002 | Glumetza | metformin hydrochloride | Santarus, Inc. | NDA | Current |
| 68012-003 | Glumetza | metformin hydrochloride | Santarus, Inc. | NDA | Current |
| 68012-003 | Glumetza | metformin hydrochloride | Santarus, Inc. | NDA | Current |
| 68012-003 | Glumetza | metformin hydrochloride | Santarus, Inc. | NDA | Current |
| 68012-003 | Glumetza | metformin hydrochloride | Santarus, Inc. | NDA | Current |
| 68012-004 | Glumetza | metformin hydrochloride | Santarus, Inc. | NDA | Current |
| 68012-004 | Glumetza | metformin hydrochloride | Santarus, Inc. | NDA | Current |
| 68012-004 | Glumetza | metformin hydrochloride | Santarus, Inc. | NDA | Current |
| 68012-004 | Glumetza | metformin hydrochloride | Santarus, Inc. | NDA | Current |
| 68682-017 | Metformin hydrochloride | metformin hydrochloride | Oceanside Pharmaceuticals | NDA AUTHORIZED GENERIC | Current |
| 68682-018 | Metformin hydrochloride | metformin hydrochloride | Oceanside Pharmaceuticals | NDA AUTHORIZED GENERIC | Current |
| 68682-018 | Metformin hydrochloride | metformin hydrochloride | Oceanside Pharmaceuticals | NDA AUTHORIZED GENERIC | Current |
| 68682-018 | Metformin hydrochloride | metformin hydrochloride | Oceanside Pharmaceuticals | NDA AUTHORIZED GENERIC | Current |
| 68682-021 | Metformin hydrochloride | metformin hydrochloride | Oceanside Pharmaceuticals | NDA AUTHORIZED GENERIC | Current |
| 68682-021 | Metformin hydrochloride | metformin hydrochloride | Oceanside Pharmaceuticals | NDA AUTHORIZED GENERIC | Current |
| 68682-021 | Metformin hydrochloride | metformin hydrochloride | Oceanside Pharmaceuticals | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 56459 | SUPPL | 2018-11-15 |
| 56400 | SUPPL | 2018-11-09 |
| 47927 | SUPPL | 2017-04-11 |
| 6111 | SUPPL | 2011-04-19 |
| 37577 | SUPPL | 2011-04-15 |
| 28515 | SUPPL | 2010-03-03 |
| 28514 | SUPPL | 2009-06-23 |
| 37576 | SUPPL | 2009-06-22 |
| 37575 | SUPPL | 2006-11-06 |
| 6110 | SUPPL | 2006-11-06 |
| 21802 | ORIG | 2006-09-07 |
| 28513 | ORIG | 2005-06-07 |
| 16302 | ORIG | 2005-06-07 |