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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
September 8, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Clopidogrel(75 mg in 1 1)

Products2

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
69367-200
Application Number
ANDA204165
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
July 31, 2023
Code: 08I79HTP27Class: ACTIMQuantity: 75 mg in 1 1
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEYClass: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT

Clopidogrel

Product Details

NDC Product Code
69367-194
Application Number
ANDA204165
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
July 31, 2023
Code: 08I79HTP27Class: ACTIMQuantity: 300 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEYClass: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
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