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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
Major Pharmaceuticals
DUNS: 191427277
Effective Date
August 28, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Clopidogrel(300 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
0904-6467
Application Number
ANDA076274
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
August 28, 2023
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MKClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
Code: 08I79HTP27Class: ACTIMQuantity: 300 mg in 1 1
METHYLCELLULOSE (15 MPA.S)Inactive
Code: NPU9M2E6L8Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
ZINC STEARATEInactive
Code: H92E6QA4FVClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
HYDROXYPROPYL CELLULOSE (70000 WAMW)Inactive
Code: 66O7AQV0RTClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3BClass: IACT
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