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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Fish and Richardson
Cantor Fitzgerald
Harvard Business School
QuintilesIMS
Julphar

Generated: May 24, 2019

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Generic Companies with Tentative Approvals for: Roxane

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Roxane 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.

Applicant Generic Name NDA Strength Dosage Form
Roxane terbinafine hydrochloride 077223 EQ 250MG BASE TABLET;ORAL
Roxane lamotrigine 077392 100MG TABLET;ORAL
Roxane nefazodone hydrochloride 076196 200MG TABLET;ORAL
Roxane tapentadol 205057 100MG TABLET;ORAL
Roxane nefazodone hydrochloride 076196 100MG TABLET;ORAL
Roxane fluconazole 076213 100MG TABLET;ORAL
Roxane mirtazapine 076270 15MG TABLET;ORAL
Applicant Generic Name NDA Strength Dosage Form

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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Fish and Richardson
Queensland Health
AstraZeneca
Merck
McKesson

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