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FDA Approval

Carbidopa and Levodopa

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

FDA Approval Summary

Company
Aurobindo Pharma Limited
DUNS: 650082092
Effective Date
December 13, 2022
Labeling Type
Human Prescription Drug Label
Carbidopa(10 mg in 1 1)
Levodopa(100 mg in 1 1)

Manufacturing Establishments1

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

APL HEALTHCARE LIMITED

Aurobindo Pharma Limited

650918514

Products3

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
59651-456
Application Number
ANDA216537
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
December 13, 2022
CarbidopaActive
Code: MNX7R8C5VOClass: ACTIMQuantity: 10 mg in 1 1
CROSPOVIDONE (35 .MU.M)Inactive
Code: 40UAA97IT9Class: IACT
HYDROXYPROPYL CELLULOSE (110000 WAMW)Inactive
Code: 5Y0974F5PWClass: IACT
LevodopaActive
Code: 46627O600JClass: ACTIBQuantity: 100 mg in 1 1
FD&C BLUE NO. 2--ALUMINUM LAKEInactive
Code: 4AQJ3LG584Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT

Carbidopa and Levodopa

Product Details

NDC Product Code
59651-457
Application Number
ANDA216537
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
December 13, 2022
CarbidopaActive
Code: MNX7R8C5VOClass: ACTIMQuantity: 25 mg in 1 1
CROSPOVIDONE (35 .MU.M)Inactive
Code: 40UAA97IT9Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
LevodopaActive
Code: 46627O600JClass: ACTIBQuantity: 100 mg in 1 1
HYDROXYPROPYL CELLULOSE (110000 WAMW)Inactive
Code: 5Y0974F5PWClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT

Carbidopa and Levodopa

Product Details

NDC Product Code
59651-458
Application Number
ANDA216537
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
December 13, 2022
LevodopaActive
Code: 46627O600JClass: ACTIBQuantity: 250 mg in 1 1
CarbidopaActive
Code: MNX7R8C5VOClass: ACTIMQuantity: 25 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
HYDROXYPROPYL CELLULOSE (110000 WAMW)Inactive
Code: 5Y0974F5PWClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
FD&C BLUE NO. 2--ALUMINUM LAKEInactive
Code: 4AQJ3LG584Class: IACT
CROSPOVIDONE (35 .MU.M)Inactive
Code: 40UAA97IT9Class: IACT
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