Details for New Drug Application (NDA): 211533
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NDA 211533 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 211533
| Tradename: | DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE |
| Applicant: | Msn |
| Ingredient: | dapagliflozin; saxagliptin hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 211533
| Mechanism of Action | Sodium-Glucose Transporter 2 Inhibitors |
Suppliers and Packaging for NDA: 211533
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE | dapagliflozin; saxagliptin hydrochloride | TABLET;ORAL | 211533 | ANDA | Novadoz Pharmaceuticals LLC | 72205-438 | 72205-438-01 | 30 TABLET, FILM COATED in 1 BOTTLE (72205-438-01) |
| DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE | dapagliflozin; saxagliptin hydrochloride | TABLET;ORAL | 211533 | ANDA | Novadoz Pharmaceuticals LLC | 72205-438 | 72205-438-02 | 90 TABLET, FILM COATED in 1 BOTTLE (72205-438-02) |
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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