Details for New Drug Application (NDA): 205941
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NDA 205941 describes SAXAGLIPTIN, which is a drug marketed by Amneal, Aurobindo Pharma, Glenmark Pharms Ltd, Mylan, and Sun Pharm, and is included in seven NDAs. It is available from four suppliers. Additional details are available on the SAXAGLIPTIN profile page.
The generic ingredient in SAXAGLIPTIN is metformin hydrochloride; saxagliptin hydrochloride. 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; saxagliptin hydrochloride profile page.
The generic ingredient in SAXAGLIPTIN is metformin hydrochloride; saxagliptin hydrochloride. 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; saxagliptin hydrochloride profile page.
Summary for 205941
| Tradename: | SAXAGLIPTIN |
| Applicant: | Amneal |
| Ingredient: | saxagliptin hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 205941
| Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Suppliers and Packaging for NDA: 205941
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SAXAGLIPTIN | saxagliptin hydrochloride | TABLET;ORAL | 205941 | ANDA | Amneal Pharmaceuticals LLC | 65162-059 | 65162-059-03 | 30 TABLET, FILM COATED in 1 BOTTLE (65162-059-03) |
| SAXAGLIPTIN | saxagliptin hydrochloride | TABLET;ORAL | 205941 | ANDA | Amneal Pharmaceuticals LLC | 65162-059 | 65162-059-09 | 90 TABLET, FILM COATED in 1 BOTTLE (65162-059-09) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 2.5MG BASE | ||||
| Approval Date: | Jul 31, 2023 | TE: | RLD: | No | |||||
| Regulatory Exclusivity Expiration: | Jan 27, 2024 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Jul 31, 2023 | TE: | RLD: | No | |||||
| Regulatory Exclusivity Expiration: | Jan 27, 2024 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
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