Regulatory Exclusivity: NEW PRODUCT

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Drugs with New Product Regulatory Exclusivity

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Exclusivity Expiration	Patented / Exclusive Use
Redhill	TALICIA	amoxicillin; omeprazole magnesium; rifabutin	CAPSULE, DELAYED RELEASE;ORAL	213004-001	Nov 1, 2019		RX	Yes	Yes	⤷ Sign Up	NEW PRODUCT
Viiv Hlthcare	SELZENTRY	maraviroc	SOLUTION;ORAL	208984-001	Nov 4, 2016		RX	Yes	Yes	⤷ Sign Up	NEW PATIENT POPULATION
Innocoll	POSIMIR	bupivacaine	SOLUTION;INFILTRATION	204803-001	Feb 1, 2021		RX	Yes	Yes	⤷ Sign Up	NEW PRODUCT
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Exclusivity Expiration	>Patented / Exclusive Use

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