Details for New Drug Application (NDA): 202425
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NDA 202425 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 202425
| Tradename: | SITAGLIPTIN PHOSPHATE |
| Applicant: | Apotex |
| Ingredient: | sitagliptin phosphate |
| Patents: | 0 |
Pharmacology for NDA: 202425
| Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Medical Subject Heading (MeSH) Categories for 202425
Suppliers and Packaging for NDA: 202425
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SITAGLIPTIN PHOSPHATE | sitagliptin phosphate | TABLET;ORAL | 202425 | ANDA | Apotex Corp. | 60505-3643 | 60505-3643-3 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60505-3643-3) |
| SITAGLIPTIN PHOSPHATE | sitagliptin phosphate | TABLET;ORAL | 202425 | ANDA | Apotex Corp. | 60505-3643 | 60505-3643-9 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60505-3643-9) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 25MG BASE | ||||
| Approval Date: | Jan 20, 2026 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Nov 24, 2026 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 50MG BASE | ||||
| Approval Date: | Jan 20, 2026 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Nov 24, 2026 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | Jan 20, 2026 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Nov 24, 2026 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
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