Details for New Drug Application (NDA): 211537
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NDA 211537 describes DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE, which is a drug marketed by MSN and Torrent and is included in two NDAs. It is available from one supplier. Additional details are available on the DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE profile page.
The generic ingredient in DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE is dapagliflozin; saxagliptin hydrochloride. There are twenty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dapagliflozin; saxagliptin hydrochloride profile page.
The generic ingredient in DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE is dapagliflozin; saxagliptin hydrochloride. There are twenty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dapagliflozin; saxagliptin hydrochloride profile page.
Summary for 211537
| Tradename: | DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE |
| Applicant: | Torrent |
| Ingredient: | dapagliflozin; saxagliptin hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG;EQ 5MG BASE | ||||
| Approval Date: | Apr 6, 2026 | TE: | AB | RLD: | No | ||||
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