Details for New Drug Application (NDA): 212687
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The generic ingredient in PIRFENIDONE is pirfenidone. There are twenty-three drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the pirfenidone profile page.
Summary for 212687
Tradename: | PIRFENIDONE |
Applicant: | Apotex |
Ingredient: | pirfenidone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 267MG | ||||
Approval Date: | Jun 9, 2023 | TE: | RLD: | No |
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