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Last Updated: August 6, 2020

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Details for New Drug Application (NDA): 210874

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NDA 210874 describes QTERNMET XR, which is a drug marketed by Astrazeneca Ab and is included in one NDA. It is available from one supplier. There are ten patents protecting this drug. Additional details are available on the QTERNMET XR profile page.

The generic ingredient in QTERNMET XR is dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride. There are twenty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride profile page.
Summary for 210874
Generic Entry Opportunity Date for 210874
Generic Entry Date for 210874*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, EXTENDED RELEASE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Suppliers and Packaging for NDA: 210874
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
QTERNMET XR dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 210874 NDA AstraZeneca Pharmaceuticals LP 0310-6925 0310-6925-60 60 TABLET, FILM COATED in 1 BOTTLE (0310-6925-60)
QTERNMET XR dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 210874 NDA AstraZeneca Pharmaceuticals LP 0310-6950 0310-6950-60 60 TABLET, FILM COATED in 1 BOTTLE (0310-6950-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength2.5MG;1GM;EQ 2.5MG BASE
Approval Date:May 2, 2019TE:RLD:Yes
Regulatory Exclusivity Expiration:May 2, 2022
Regulatory Exclusivity Use:NEW PRODUCT
Patent:  Start TrialPatent Expiration:Oct 4, 2020Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF TYPE 2 DIABETES MELLITUS
Patent:  Start TrialPatent Expiration:Oct 4, 2020Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF TYPE 2 DIABETES MELLITUS

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