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FDA Approval

CARBIDOPA

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

FDA Approval Summary

Company
Effective Date
October 13, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Carbidopa(25 mg in 1 1)

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
70771-1355
Application Number
ANDA209910
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
October 13, 2022
CELLULOSE, 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
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