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Last Updated: September 30, 2020

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Generic Companies with Tentative Approvals for: Zydus

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Zydus 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
Zydus Pharms minocycline hydrochloride 203553 EQ 80MG BASE TABLET, EXTENDED RELEASE;ORAL
Zydus Pharms Usa Inc lorcaserin hydrochloride 209464 10MG TABLET; ORAL
Zydus Pharms Usa desloratadine 078353 5MG TABLET; ORAL
Zydus Pharms Usa Inc amlodipine besylate; benazepril hydrochloride 078652 10MG; 20MG CAPSULE; ORAL
Zydus Pharms Usa Inc letrozole 090405 2.5MG TABLET; ORAL
Zydus Pharms Usa Inc metformin hydrochloride;sitagliptin phosphate 208535 50MG/500MG;50MG/1000MG TABLET;ORAL
>Applicant >Generic Name >NDA >Strength >Dosage Form

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Serving leading biopharmaceutical companies globally:

Express Scripts
Harvard Business School
Boehringer Ingelheim

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