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.

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Glossary

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Applicant	Generic Name	NDA	Strength	Dosage Form
Teva Pharms Usa	sitagliptin phosphate	202487	25MG	TABLET;ORAL
Alkem Labs Ltd	tapentadol	205015	75MG	TABLET;ORAL
Par Pharm Inc	dextromethorphan hydrobromide;quinidine sulfate	202993	20MG;10MG	CAPSULE;ORAL
Cipla Limited	lamivudine; zidovudine	201151	30MG; 60MG	TABLET; ORAL
Wockhardt	duloxetine hydrochloride	090773	20MG	CAPSULE, DELAYED RELEASE; ORAL
>Applicant	>Generic Name	>NDA	>Strength	>Dosage Form

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