Details for New Drug Application (NDA): 202387
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NDA 202387 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 one supplier. 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. Four 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. Four suppliers are listed for this compound. Additional details are available on the sitagliptin phosphate profile page.
Summary for 202387
| Tradename: | SITAGLIPTIN PHOSPHATE |
| Applicant: | Sandoz |
| Ingredient: | sitagliptin phosphate |
| Patents: | 0 |
Pharmacology for NDA: 202387
| Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Medical Subject Heading (MeSH) Categories for 202387
Suppliers and Packaging for NDA: 202387
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SITAGLIPTIN PHOSPHATE | sitagliptin phosphate | TABLET;ORAL | 202387 | ANDA | Sandoz Inc | 0781-5766 | 0781-5766-31 | 30 TABLET, FILM COATED in 1 BOTTLE (0781-5766-31) |
| SITAGLIPTIN PHOSPHATE | sitagliptin phosphate | TABLET;ORAL | 202387 | ANDA | Sandoz Inc | 0781-5766 | 0781-5766-92 | 90 TABLET, FILM COATED in 1 BOTTLE (0781-5766-92) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 25MG BASE | ||||
| Approval Date: | Jan 14, 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 14, 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 14, 2026 | TE: | AB | RLD: | No | ||||
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