Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Zydus Lifesciences Limited
918596198
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Zydus Lifesciences Limited
Zydus Lifesciences Limited
Zydus Lifesciences Limited
918596198
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
pioglitazone
Product Details
NDC Product Code
70771-1022Application Number
ANDA202456Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 27, 2023PioglitazoneActive
Code: JQT35NPK6CClass: ACTIMQuantity: 30 mg in 1 1
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93LClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
pioglitazone
Product Details
NDC Product Code
70771-1021Application Number
ANDA202456Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 27, 2023PioglitazoneActive
Code: JQT35NPK6CClass: ACTIMQuantity: 15 mg in 1 1
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93LClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
pioglitazone
Product Details
NDC Product Code
70771-1023Application Number
ANDA202456Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 27, 2023PioglitazoneActive
Code: JQT35NPK6CClass: ACTIMQuantity: 45 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93LClass: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT