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. Additional details are available on the SITAGLIPTIN PHOSPHATE profile page.
The generic ingredient in SITAGLIPTIN PHOSPHATE is sitagliptin phosphate. There are thirty-five drug master file entries for this compound. Three 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 are thirty-five drug master file entries for this compound. Three 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 |
Medical Subject Heading (MeSH) Categories for 202425
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 | ||||
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 | ||||
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 | ||||
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