Approvals/TGA/XIGDUO XR 5/1000 dapagliflozin 5 mg (as propanediol monohydrate) / metformin hydrochloride 1000 mg modified release tablets blister pack

Approved

STANDARD

XIGDUO XR 5/1000 dapagliflozin 5 mg (as propanediol monohydrate) / metformin hydrochloride 1000 mg modified release tablets blister pack

AstraZeneca Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Date: Dec 9, 2025
Approval ID: e09f519cad846ea4
Company: AstraZeneca Pty Ltd
Type: Standard

Approval Details

Approval Id: e09f519cad846ea4
Product Name: XIGDUO XR 5/1000 dapagliflozin 5 mg (as propanediol monohydrate) / metformin hydrochloride 1000 mg modified release tablets blister pack
Artg Id: 211296
Artg Name: XIGDUO XR 5/1000 dapagliflozin 5 mg (as propanediol monohydrate) / metformin hydrochloride 1000 mg modified release tablets blister pack
Sponsor: AstraZeneca Pty Ltd
Company Detail Path: /organization/astrazeneca-pty-ltd
Artg Date: 2014-07-18
Registration Type: Medicine
Therapeutic Good Type: Medicine
Licence Status: A
Licence Category: RE
Consumer Medicine Info: https://medical-cdn.nocode.com/drug_tga/27503a567d34944857daddd07bbf963e.pdf
Product Information: https://medical-cdn.nocode.com/drug_tga/7c927bdea9504cd942993ae6972e50cf.pdf

Approved

Quick Info

Agency

TGA

Country

🇦🇺

Approval Date

Dec 9, 2025

Approval ID

e09f519cad846ea4

Type

Standard

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