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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 213351

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CLOPIDOGREL BISULFATE (CLOPIDOGREL BISULFATE)
EQ 75MG BASE
Marketing Status: Prescription
Active Ingredient: CLOPIDOGREL BISULFATE
Proprietary Name: CLOPIDOGREL BISULFATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 75MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213351
Product Number: 001
Approval Date: Jul 17, 2020
Applicant Holder Full Name: POLYGEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
CLOPIDOGREL BISULFATE (CLOPIDOGREL BISULFATE)
EQ 300MG BASE
Marketing Status: Prescription
Active Ingredient: CLOPIDOGREL BISULFATE
Proprietary Name: CLOPIDOGREL BISULFATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 300MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213351
Product Number: 002
Approval Date: Jul 17, 2020
Applicant Holder Full Name: POLYGEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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