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
863362789
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
CARBIDOPA
Product Details
NDC Product Code
70771-1355Application Number
ANDA209910Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 13, 2022CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
CarbidopaActive
Code: MNX7R8C5VOClass: ACTIMQuantity: 25 mg in 1 1
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT