Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208780

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ESBRIET (PIRFENIDONE)
267MG
Marketing Status: Prescription

Active Ingredient: PIRFENIDONE
Proprietary Name: ESBRIET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 267MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N208780
Product Number: 001
Approval Date: Jan 11, 2017
Applicant Holder Full Name: GENENTECH INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ESBRIET (PIRFENIDONE)
801MG
Marketing Status: Prescription

Active Ingredient: PIRFENIDONE
Proprietary Name: ESBRIET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 801MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N208780
Product Number: 003
Approval Date: Jan 11, 2017
Applicant Holder Full Name: GENENTECH INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ESBRIET (PIRFENIDONE)
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: PIRFENIDONE
Proprietary Name: ESBRIET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208780
Product Number: 002
Approval Date: Jan 11, 2017
Applicant Holder Full Name: GENENTECH INC
Marketing Status:  Discontinued
Patent and Exclusivity Information