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FDA Approval

Carbidopa-levodopa

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

FDA Approval Summary

Company
TruPharma, LLC
DUNS: 078533947
Effective Date
April 8, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Carbidopa(25 mg in 1 1)
Levodopa(250 mg in 1 1)

Manufacturing Establishments1

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

Rubicon Research Private Limited

TruPharma, LLC

677604197

Products3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Carbidopa-levodopa

Product Details

NDC Product Code
52817-392
Application Number
ANDA216505
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
April 8, 2023
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
CarbidopaActive
Code: MNX7R8C5VOClass: ACTIMQuantity: 25 mg in 1 1
LevodopaActive
Code: 46627O600JClass: ACTIBQuantity: 250 mg in 1 1
FD&C BLUE NO. 2--ALUMINUM LAKEInactive
Code: 4AQJ3LG584Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT

Carbidopa-levodopa

Product Details

NDC Product Code
52817-390
Application Number
ANDA216505
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
April 8, 2023
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
FD&C BLUE NO. 2--ALUMINUM LAKEInactive
Code: 4AQJ3LG584Class: IACT
LevodopaActive
Code: 46627O600JClass: ACTIBQuantity: 100 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CarbidopaActive
Code: MNX7R8C5VOClass: ACTIMQuantity: 10 mg in 1 1

Carbidopa-levodopa

Product Details

NDC Product Code
52817-391
Application Number
ANDA216505
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
April 8, 2023
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6Class: IACT
LevodopaActive
Code: 46627O600JClass: ACTIBQuantity: 100 mg in 1 1
CarbidopaActive
Code: MNX7R8C5VOClass: ACTIMQuantity: 25 mg in 1 1
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