Details for New Drug Application (NDA): 202327
NDA 202327 describes SITAGLIPTIN PHOSPHATE, which is a drug marketed by Apotex, Sandoz, and Watson Labs Inc, and is included in three NDAs. It is available from four suppliers. Additional details are available on the SITAGLIPTIN PHOSPHATE profile page.
The generic ingredient in SITAGLIPTIN PHOSPHATE is sitagliptin phosphate. There is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the sitagliptin phosphate profile page.
The generic ingredient in SITAGLIPTIN PHOSPHATE is sitagliptin phosphate. There is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the sitagliptin phosphate profile page.
Summary for 202327
| Tradename: | SITAGLIPTIN PHOSPHATE |
| Applicant: | Watson Labs Inc |
| Ingredient: | sitagliptin phosphate |
| Patents: | 0 |
Pharmacology for NDA: 202327
| Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Medical Subject Heading (MeSH) Categories for 202327
Suppliers and Packaging for NDA: 202327
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SITAGLIPTIN PHOSPHATE | sitagliptin phosphate | TABLET;ORAL | 202327 | ANDA | Teva Pharmaceuticals, Inc. | 0480-2607 | 0480-2607-56 | 30 TABLET, FILM COATED in 1 BOTTLE (0480-2607-56) |
| SITAGLIPTIN PHOSPHATE | sitagliptin phosphate | TABLET;ORAL | 202327 | ANDA | Teva Pharmaceuticals, Inc. | 0480-2607 | 0480-2607-98 | 90 TABLET, FILM COATED in 1 BOTTLE (0480-2607-98) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 25MG BASE | ||||
| Approval Date: | Dec 30, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 50MG BASE | ||||
| Approval Date: | Dec 30, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | Dec 30, 2025 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
