Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
ScieGen Pharmaceuticals Inc
079391286
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
ScieGen Pharmaceuticals Inc
Radha Pharmaceuticals Inc
ScieGen Pharmaceuticals Inc
079391286
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Carbidopa and Levodopa
Product Details
NDC Product Code
77771-460Application Number
ANDA214091Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
April 25, 2025HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
CarbidopaActive
Code: MNX7R8C5VOClass: ACTIMQuantity: 25 mg in 1 1
LevodopaActive
Code: 46627O600JClass: ACTIBQuantity: 100 mg in 1 1
Carbidopa and Levodopa
Product Details
NDC Product Code
77771-461Application Number
ANDA214091Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
April 25, 2025HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
CarbidopaActive
Code: MNX7R8C5VOClass: ACTIMQuantity: 50 mg in 1 1
LevodopaActive
Code: 46627O600JClass: ACTIBQuantity: 200 mg in 1 1