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Last Updated: October 27, 2021

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Generic Companies with Tentative Approvals for: pirfenidone


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pirfenidone Generic Filers with Tentative Approvals

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Applicant Generic Name NDA Strength Dosage Form
Granules India pirfenidone 212615 801MG TABLET;ORAL
Apotex Inc pirfenidone 212687 267MG CAPSULE;ORAL
Pharmaq, Inc. pirfenidone 212722 267MG TABLET; ORAL
Micro Labs Ltd pirfenidone 212680 267MG TABLET; ORAL
Granules India pirfenidone 212615 267MG TABLET;ORAL
Micro Labs Ltd pirfenidone 212680 534MG TABLET;ORAL
Micro Labs Ltd pirfenidone 212680 801MG TABLET;ORAL
>Applicant >Generic Name >NDA >Strength >Dosage Form

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Serving leading biopharmaceutical companies globally:

Baxter
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Merck
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AstraZeneca

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