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FDA Approval

Pioglitazole and metformin hydrochloride

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
October 18, 2022
Labeling Type
Human Prescription Drug Label
Pioglitazone(15 mg in 1 1)
Metformin(850 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Macleods Pharmaceuticals Limited

Macleods Pharmaceuticals Limited

676369519

Products2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Pioglitazole and metformin hydrochloride

Product Details

NDC Product Code
33342-177
Application Number
ANDA204802
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
October 18, 2022
Code: JQT35NPK6CClass: ACTIMQuantity: 15 mg in 1 1
MetforminActive
Code: 786Z46389EClass: ACTIBQuantity: 850 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT

Pioglitazole and metformin hydrochloride

Product Details

NDC Product Code
33342-176
Application Number
ANDA204802
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
October 18, 2022
Code: JQT35NPK6CClass: ACTIMQuantity: 15 mg in 1 1
MetforminActive
Code: 786Z46389EClass: ACTIBQuantity: 500 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
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