Product Details for NDA 022350
ONGLYZA (SAXAGLIPTIN HYDROCHLORIDE)
EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: SAXAGLIPTIN HYDROCHLORIDE
Proprietary Name: ONGLYZA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N022350
Product Number: 001
Approval Date: Jul 31, 2009
Applicant Holder Full Name: ASTRAZENECA AB
Marketing Status: Discontinued
Patent and Exclusivity Information
ONGLYZA (SAXAGLIPTIN HYDROCHLORIDE)
Proprietary Name: ONGLYZA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N022350
Product Number: 001
Approval Date: Jul 31, 2009
Applicant Holder Full Name: ASTRAZENECA AB
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: SAXAGLIPTIN HYDROCHLORIDE
Proprietary Name: ONGLYZA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N022350
Product Number: 002
Approval Date: Jul 31, 2009
Applicant Holder Full Name: ASTRAZENECA AB
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: ONGLYZA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N022350
Product Number: 002
Approval Date: Jul 31, 2009
Applicant Holder Full Name: ASTRAZENECA AB
Marketing Status: Discontinued
Patent and Exclusivity Information