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Details for New Drug Application (NDA): 205649

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NDA 205649 describes XIGDUO XR, which is a drug marketed by Astrazeneca Ab and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the XIGDUO XR profile page.

The generic ingredient in XIGDUO XR is dapagliflozin propanediol; metformin hydrochloride. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dapagliflozin propanediol; metformin hydrochloride profile page.

Summary for NDA: 205649

Astrazeneca Ab
dapagliflozin propanediol; metformin hydrochloride
Formulation / Manufacturing:see details

Pharmacology for NDA: 205649

Mechanism of ActionSodium-Glucose Transporter 2 Inhibitors

Suppliers and Packaging for NDA: 205649

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
dapagliflozin propanediol; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL 205649 NDA AstraZeneca Pharmaceuticals LP 0310-6250 0310-6250-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0310-6250-30)
dapagliflozin propanediol; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL 205649 NDA AstraZeneca Pharmaceuticals LP 0310-6250 0310-6250-95 1 BLISTER PACK in 1 CARTON (0310-6250-95) > 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 5MG BASE;500MG
Approval Date:Oct 29, 2014TE:RLD:Yes
Patent:7,919,598Patent Expiration:Dec 16, 2029Product Flag?Substance Flag?YDelist Request?
Regulatory Exclusivity Expiration:Jan 8, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:6,414,126Patent Expiration:Oct 4, 2020Product Flag?YSubstance Flag?YDelist Request?

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