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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 215388


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NDA 215388 describes CLOPIDOGREL BISULFATE, which is a drug marketed by Accord Hlthcare, Acme Labs, Actavis Totowa, Alkem Labs Ltd, Amneal Pharms, Ani Pharms, Apotex Inc, Aurobindo Pharma Ltd, Chartwell Rx, Dr Reddys, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Macleods Pharms Ltd, MSN, Polygen Pharms, Prinston Inc, Rising, Sciegen Pharms Inc, Sun Pharm, Sun Pharm Industries, Teva, Torrent Pharms Ltd, and Zydus Lifesciences, and is included in twenty-five NDAs. It is available from thirty-eight suppliers. Additional details are available on the CLOPIDOGREL BISULFATE profile page.

The generic ingredient in CLOPIDOGREL BISULFATE is clopidogrel bisulfate. There are fifty-four drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the clopidogrel bisulfate profile page.
Summary for 215388
Tradename:CLOPIDOGREL BISULFATE
Applicant:Msn
Ingredient:clopidogrel bisulfate
Patents:0
Pharmacology for NDA: 215388
Mechanism of ActionCytochrome P450 2C8 Inhibitors
P2Y12 Receptor Antagonists
Physiological EffectDecreased Platelet Aggregation
Suppliers and Packaging for NDA: 215388
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOPIDOGREL BISULFATE clopidogrel bisulfate TABLET;ORAL 215388 ANDA Novadoz Pharmaceuticals LLC 72205-199 72205-199-01 1000 TABLET, FILM COATED in 1 BOTTLE (72205-199-01)
CLOPIDOGREL BISULFATE clopidogrel bisulfate TABLET;ORAL 215388 ANDA Novadoz Pharmaceuticals LLC 72205-199 72205-199-05 500 TABLET, FILM COATED in 1 BOTTLE (72205-199-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 75MG BASE
Approval Date:Sep 20, 2024TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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