Details for New Drug Application (NDA): 202388
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NDA 202388 describes SITAGLIPTIN AND METFORMIN HYDROCHLORIDE, which is a drug marketed by Ph Health and Sandoz and is included in two NDAs. It is available from one supplier. Additional details are available on the SITAGLIPTIN AND METFORMIN HYDROCHLORIDE profile page.
The generic ingredient in SITAGLIPTIN AND METFORMIN HYDROCHLORIDE is metformin hydrochloride; sitagliptin phosphate. 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 phosphate profile page.
The generic ingredient in SITAGLIPTIN AND METFORMIN HYDROCHLORIDE is metformin hydrochloride; sitagliptin phosphate. 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 phosphate profile page.
Summary for 202388
| Tradename: | SITAGLIPTIN AND METFORMIN HYDROCHLORIDE |
| Applicant: | Sandoz |
| Ingredient: | metformin hydrochloride; sitagliptin phosphate |
| Patents: | 0 |
Pharmacology for NDA: 202388
| Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Suppliers and Packaging for NDA: 202388
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE | metformin hydrochloride; sitagliptin phosphate | TABLET;ORAL | 202388 | ANDA | Sandoz Inc | 0781-5801 | 0781-5801-05 | 500 TABLET, FILM COATED in 1 BOTTLE (0781-5801-05) |
| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE | metformin hydrochloride; sitagliptin phosphate | TABLET;ORAL | 202388 | ANDA | Sandoz Inc | 0781-5801 | 0781-5801-60 | 60 TABLET, FILM COATED in 1 BOTTLE (0781-5801-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG;EQ 50MG BASE | ||||
| Approval Date: | Dec 2, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1GM;EQ 50MG BASE | ||||
| Approval Date: | Dec 2, 2025 | TE: | AB | RLD: | No | ||||
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