Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 212747

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PIRFENIDONE (PIRFENIDONE)
267MG
Marketing Status: Prescription

Active Ingredient: PIRFENIDONE
Proprietary Name: PIRFENIDONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 267MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A212747
Product Number: 001
Approval Date: Jul 21, 2022
Applicant Holder Full Name: AIZANT DRUG RESEARCH SOLUTIONS PRIVATE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

PIRFENIDONE (PIRFENIDONE)
534MG
Marketing Status: Prescription

Active Ingredient: PIRFENIDONE
Proprietary Name: PIRFENIDONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 534MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A212747
Product Number: 002
Approval Date: Jul 21, 2022
Applicant Holder Full Name: AIZANT DRUG RESEARCH SOLUTIONS PRIVATE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

PIRFENIDONE (PIRFENIDONE)
801MG
Marketing Status: Prescription

Active Ingredient: PIRFENIDONE
Proprietary Name: PIRFENIDONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 801MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A212747
Product Number: 003
Approval Date: Jul 21, 2022
Applicant Holder Full Name: AIZANT DRUG RESEARCH SOLUTIONS PRIVATE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information