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Last Updated: August 8, 2020

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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
Mylan Pharms Inc lisdexamfetamine dimesylate 202835 20MG CAPSULE;ORAL
Sandoz oxaliplatin 078817 100MG/20ML (5MG/ML) INJECTABLE;INTRAVENOUS
Alkem Labs Ltd lurasidone hydrochloride 212244 20MG TABLET;ORAL
Apotex Inc levocetirizine dihydrochloride 211528 2.5MG/5ML SOLUTION;ORAL
Teva Pharms Usa darunavir 202118 400MG TABLET;ORAL
Lupin Ltd diclofenac sodium 208021 2% SOLUTION;TOPICAL
>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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