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Last Updated: October 17, 2021

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Generic Companies with Tentative Approvals for: Lupin

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Lupin 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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Glossary

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Applicant	Generic Name	NDA	Strength	Dosage Form
Lupin Ltd	minocycline hydrochloride	091424	EQ 135MG BASE	TABLET, EXTENDED RELEASE;ORAL
Lupin Ltd	pregabalin	091040	75MG	CAPSULE;ORAL
Lupin Ltd	hydrochlorothiazide; irbesartan	201524	12.5MG;150MG	TABLET;ORAL
Lupin Ltd	diclofenac	207393	35MG	CAPSULE;ORAL
Lupin Ltd	balsalazide disodium	206529	1.1GM	TABLET;ORAL
>Applicant	>Generic Name	>NDA	>Strength	>Dosage Form

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