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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 205972


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NDA 205972 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.
Summary for 205972
Tradename:SAXAGLIPTIN
Applicant:Aurobindo Pharma
Ingredient:saxagliptin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 205972
Suppliers and Packaging for NDA: 205972
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SAXAGLIPTIN saxagliptin hydrochloride TABLET;ORAL 205972 ANDA Aurobindo Pharma Limited 65862-825 65862-825-01 100 TABLET, FILM COATED in 1 BOTTLE (65862-825-01)
SAXAGLIPTIN saxagliptin hydrochloride TABLET;ORAL 205972 ANDA Aurobindo Pharma Limited 65862-825 65862-825-05 500 TABLET, FILM COATED in 1 BOTTLE (65862-825-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2.5MG BASE
Approval Date:Jul 31, 2023TE:ABRLD:No
Regulatory Exclusivity Expiration:Jan 27, 2024
Regulatory Exclusivity Use:PATENT CHALLENGE

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Jul 31, 2023TE:ABRLD:No
Regulatory Exclusivity Expiration:Jan 27, 2024
Regulatory Exclusivity Use:PATENT CHALLENGE

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