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
Mylan Pharms Inc	fluconazole	076042	150MG	TABLET;ORAL
Micro Labs Ltd	lamivudine	200406	300MG	TABLET; ORAL
Cadila Pharms Ltd	pregabalin	206452	225MG	CAPSULE;ORAL
Mylan Pharms Inc	dalfampridine	206858	10MG	TABLET, EXTENDED RELEASE;ORAL
Sandoz Inc	maraviroc	203382	150MG	TABLET;ORAL
Roxane	tapentadol	205057	100MG	TABLET;ORAL
>Applicant	>Generic Name	>NDA	>Strength	>Dosage Form

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