Generic Companies with Tentative Approvals

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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
Dr Reddys Labs Ltd	lamotrigine	202383	300MG	TABLET, EXTENDED RELEASE;ORAL
Aurobindo Pharma Usa	pregabalin	205321	200MG	CAPSULE;ORAL
Watson Labs	rosiglitazone maleate	078023	4MG	TABLET; ORAL
Emcure Pharma	efavirenz	078958	600MG	TABLET; ORAL
>Applicant	>Generic Name	>NDA	>Strength	>Dosage Form

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