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FDA Approval

Clopidogrel

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

FDA Approval Summary

Company
Effective Date
November 19, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Clopidogrel(75 mg in 1 1)

Products1

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

Clopidogrel

Product Details

NDC Product Code
65162-414
Application Number
ANDA203751
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
November 19, 2022
Code: 08I79HTP27Class: ACTIMQuantity: 75 mg in 1 1
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEYClass: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
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