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Last Updated: October 20, 2019

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Generic Companies with Tentative Approvals for: Gedeon Richter Usa

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Gedeon Richter Usa 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
Gedeon Richter Usa	amlodipine besylate	077333	EQ 5MG BASE	TABLET;ORAL
Gedeon Richter Usa	fluconazole	076432	50MG	TABLET;ORAL
Gedeon Richter Usa	fluconazole	076432	200MG	TABLET;ORAL
Gedeon Richter Usa	terbinafine hydrochloride	077065	EQ 250MG BASE	TABLET;ORAL
Gedeon Richter Usa	fluconazole	076432	150MG	TABLET;ORAL
Gedeon Richter Usa	amlodipine besylate	077333	EQ 10MG BASE	TABLET;ORAL
>Applicant	>Generic Name	>NDA	>Strength	>Dosage Form

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