Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Zydus Lifesciences Limited
650199482
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Zydus Lifesciences Limited
Viona Pharmaceuticals Inc
Zydus Lifesciences Limited
918596198
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
72578-012Application Number
ANDA201686Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 20, 2022HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
ClopidogrelActive
Code: 08I79HTP27Class: ACTIMQuantity: 75 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEYClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT