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Last Updated: April 19, 2021

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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.

Applicant Generic Name NDA Strength Dosage Form
Amneal Pharms saxagliptin;metformin hydrochloride 205942 5MG;1000MG TABLET, EXTENDED RELEASE;ORAL
Emcure Pharma nevirapine 078887 200MG TABLET; ORAL
Sandoz Inc sitagliptin; metformin hydrochloride 202388 50MG; 500MG TABLET; ORAL
Accord Hlthcare Inc perampanel 209877 6MG TABLET;ORAL
Anchen Pharms metformin hydrochloride; sitagliptin phosphate 204144 1GM; EQ 50MG BASE TABLET, EXTENDED RELEASE;ORAL
Ranbaxy fexofenadine hydrochloride 076970 60MG TABLET; ORAL
Novast Labs Ltd norgestimate; ethinyl estradiol 090541 0.18MG; 0.025MG TABLET; ORAL
>Applicant >Generic Name >NDA >Strength >Dosage Form

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Serving leading biopharmaceutical companies globally:

Express Scripts
Harvard Business School
Johnson and Johnson

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