Last Updated: June 16, 2026

Generic Companies with Tentative Approvals for: darunavir

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darunavir 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.

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Applicant	Generic Name	NDA	Strength	Dosage Form
Annora Pharma	darunavir	216168	600MG	TABLET;ORAL
Micro Labs Usa	darunavir ethanolate	210187	400MG	TABLET;ORAL
Zydus Lifesciences	darunavir	214085	150MG	TABLET;ORAL
Teva Pharms Usa	darunavir	202118	400MG	TABLET;ORAL
>Applicant	>Generic Name	>NDA	>Strength	>Dosage Form

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