Last Updated: November 14, 2026

Generic Companies with Tentative Approvals

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
Purepac Pharm	naproxen	074263	375MG	TABLET;ORAL
Zydus Pharms Usa Inc	amlodipine besylate; benazepril hydrochloride	078652	5MG; 10MG	CAPSULE; ORAL
Zydus Pharms Usa Inc	levomilnacipran	210857	120MG	CAPSULE, EXTENDED RELEASE;ORAL
Teva Pharms Inc	elagolix	217642	200MG	TABLET; FILM COATED
Mylan Pharms Inc	fentanyl	202577	800MCG	TABLET;BUCCAL
Huaren Pharmaceutical Co Ltd	hydrochlorothiazide; valsartan	205439	25MG;160MG	TABLET;ORAL
>Applicant	>Generic Name	>NDA	>Strength	>Dosage Form

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