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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 205888

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PRASUGREL (PRASUGREL HYDROCHLORIDE)
EQ 5MG BASE
Marketing Status: Prescription
Active Ingredient: PRASUGREL HYDROCHLORIDE
Proprietary Name: PRASUGREL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A205888
Product Number: 001
Approval Date: Oct 16, 2017
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
PRASUGREL (PRASUGREL HYDROCHLORIDE)
EQ 10MG BASE
Marketing Status: Prescription
Active Ingredient: PRASUGREL HYDROCHLORIDE
Proprietary Name: PRASUGREL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A205888
Product Number: 002
Approval Date: Oct 16, 2017
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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