Details for New Drug Application (NDA): 216778
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NDA 216778 describes ZITUVIMET XR, which is a drug marketed by Zydus Lifesciences and is included in one NDA. It is available from two suppliers. Additional details are available on the ZITUVIMET XR profile page.
The generic ingredient in ZITUVIMET XR is metformin hydrochloride; sitagliptin. There are forty-nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the metformin hydrochloride; sitagliptin profile page.
The generic ingredient in ZITUVIMET XR is metformin hydrochloride; sitagliptin. There are forty-nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the metformin hydrochloride; sitagliptin profile page.
Summary for 216778
| Tradename: | ZITUVIMET XR |
| Applicant: | Zydus Lifesciences |
| Ingredient: | metformin hydrochloride; sitagliptin |
| Patents: | 0 |
Pharmacology for NDA: 216778
| Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Suppliers and Packaging for NDA: 216778
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZITUVIMET XR | metformin hydrochloride; sitagliptin | TABLET, EXTENDED RELEASE;ORAL | 216778 | NDA | Zydus Pharmaceuticals USA Inc. | 70710-1804 | 70710-1804-6 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70710-1804-6) |
| ZITUVIMET XR | metformin hydrochloride; sitagliptin | TABLET, EXTENDED RELEASE;ORAL | 216778 | NDA | Zydus Pharmaceuticals USA Inc. | 70710-1805 | 70710-1805-6 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70710-1805-6) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 500MG;50MG | ||||
| Approval Date: | Jul 18, 2024 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 1GM;50MG | ||||
| Approval Date: | Jul 18, 2024 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 1GM;100MG | ||||
| Approval Date: | Jul 18, 2024 | TE: | RLD: | Yes | |||||
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