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XIGDUO XR 10/500 dapagliflozin 10 mg (as propanediol monohydrate) / metformin hydrochloride 500 mg modified release tablets blister pack - TGA Drug Approval Details
Approvals
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TGA
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XIGDUO XR 10/500 dapagliflozin 10 mg (as propanediol monohydrate) / metformin hydrochloride 500 mg modified release tablets blister pack
Approved
STANDARD
XIGDUO XR 10/500 dapagliflozin 10 mg (as propanediol monohydrate) / metformin hydrochloride 500 mg modified release tablets blister pack
AstraZeneca Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
May 29, 2025
Approval ID
c1a536bdd198e6bd
Company
AstraZeneca Pty Ltd
Type
Standard
Approval Details
Approval Id
c1a536bdd198e6bd
Product Name
XIGDUO XR 10/500 dapagliflozin 10 mg (as propanediol monohydrate) / metformin hydrochloride 500 mg modified release tablets blister pack
Artg Id
211294
Artg Name
XIGDUO XR 10/500 dapagliflozin 10 mg (as propanediol monohydrate) / metformin hydrochloride 500 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
Active Ingredients
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
May 29, 2025
Approval ID
c1a536bdd198e6bd
Type
Standard
Back to TGA Approvals