Details for New Drug Application (NDA): 212198
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NDA 212198 describes EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE, which is a drug marketed by Zydus Pharms and is included in one NDA. Additional details are available on the EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE profile page.
The generic ingredient in EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE is empagliflozin; metformin hydrochloride. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the empagliflozin; metformin hydrochloride profile page.
The generic ingredient in EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE is empagliflozin; metformin hydrochloride. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the empagliflozin; metformin hydrochloride profile page.
Summary for 212198
| Tradename: | EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
| Applicant: | Zydus Pharms |
| Ingredient: | empagliflozin; metformin hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 5MG;500MG | ||||
| Approval Date: | Jul 7, 2022 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 5MG;1GM | ||||
| Approval Date: | Jul 7, 2022 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 12.5MG;500MG | ||||
| Approval Date: | Jul 7, 2022 | TE: | RLD: | No | |||||
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