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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.

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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:

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Boehringer Ingelheim

Merck

Johnson and Johnson

Express Scripts

Moodys

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