Details for New Drug Application (NDA): 211563
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NDA 211563 describes DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE, which is a drug marketed by Alkem Labs Ltd, Aurobindo Pharma, Cipla, Cipla Ltd, Lupin Ltd, Macleods Pharms Ltd, Micro Labs, MSN, Sun Pharm, and Teva Pharms Usa Inc, and is included in ten NDAs. It is available from six suppliers. Additional details are available on the DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE profile page.
The generic ingredient in DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE is dapagliflozin; metformin hydrochloride. There are twenty-six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the dapagliflozin; metformin hydrochloride profile page.
The generic ingredient in DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE is dapagliflozin; metformin hydrochloride. There are twenty-six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the dapagliflozin; metformin hydrochloride profile page.
Summary for 211563
| Tradename: | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
| Applicant: | Alkem Labs Ltd |
| Ingredient: | dapagliflozin; metformin hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 211563
| Mechanism of Action | Sodium-Glucose Transporter 2 Inhibitors |
Suppliers and Packaging for NDA: 211563
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | dapagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 211563 | ANDA | Ascend Laboratories, LLC | 67877-619 | 67877-619-05 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-619-05) |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | dapagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 211563 | ANDA | Ascend Laboratories, LLC | 67877-619 | 67877-619-30 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-619-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 5MG;500MG | ||||
| Approval Date: | Apr 6, 2026 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 5MG;1GM | ||||
| Approval Date: | Apr 6, 2026 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 10MG;500MG | ||||
| Approval Date: | Apr 6, 2026 | TE: | AB | RLD: | No | ||||
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