Details for New Drug Application (NDA): 216743
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NDA 216743 describes ZITUVIMET, which is a drug marketed by Zydus and is included in one NDA. It is available from two suppliers. Additional details are available on the ZITUVIMET profile page.
The generic ingredient in ZITUVIMET is metformin hydrochloride; sitagliptin. There are forty-nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the metformin hydrochloride; sitagliptin profile page.
The generic ingredient in ZITUVIMET is metformin hydrochloride; sitagliptin. There are forty-nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the metformin hydrochloride; sitagliptin profile page.
Summary for 216743
| Tradename: | ZITUVIMET |
| Applicant: | Zydus |
| Ingredient: | metformin hydrochloride; sitagliptin |
| Patents: | 0 |
Pharmacology for NDA: 216743
| Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Suppliers and Packaging for NDA: 216743
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZITUVIMET | metformin hydrochloride; sitagliptin | TABLET;ORAL | 216743 | NDA | Zydus Pharmaceuticals (USA) Inc. | 70710-1786 | 70710-1786-6 | 60 TABLET, FILM COATED in 1 BOTTLE (70710-1786-6) |
| ZITUVIMET | metformin hydrochloride; sitagliptin | TABLET;ORAL | 216743 | NDA | Zydus Pharmaceuticals (USA) Inc. | 70710-1786 | 70710-1786-8 | 180 TABLET, FILM COATED in 1 BOTTLE (70710-1786-8) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG;50MG | ||||
| Approval Date: | Nov 3, 2023 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1GM;50MG | ||||
| Approval Date: | Nov 3, 2023 | TE: | RLD: | Yes | |||||
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