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Last Updated: October 26, 2021

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Generic Companies with Tentative Approvals for: sitagliptin

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sitagliptin 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
Teva Pharms Usa Inc sitagliptin phosphate;metformin hydrochloride 204591 50MG;500MG TABLET, EXTENDED RELEASE;ORAL
Zydus Pharms Usa Inc sitagliptin phosphate 208186 EQ 25MG BASE TABLET;ORAL
Apotex Inc sitagliptin; metformin hydrochloride 202426 50MG; 1000MG TABLET; ORAL
Ajanta Pharma Ltd sitagliptin phosphate 214784 EQ 100MG BASE TABLET;ORAL
Watson Labs Inc sitagliptin phosphate; metformin hydrochloride 202365 50MG;1000MG TABLET;ORAL
Unichem Labs Ltd sitagliptin phosphate 214693 EQ 50MG BASE TABLET;ORAL
Apotex Inc sitagliptin phosphate 202425 50MG TABLET; ORAL
>Applicant >Generic Name >NDA >Strength >Dosage Form

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Johnson and Johnson
Express Scripts

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