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Last Updated: December 13, 2024

Lamivudine; tenofovir - Generic Drug Details

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Generic filers with tentative approvals for LAMIVUDINE; TENOFOVIR

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	300MG/300MG	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	300MG; 300MG	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	300MG; 300MG; 200MG	TABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

US Patents and Regulatory Information for lamivudine; tenofovir

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chartwell Rx	TEMIXYS	lamivudine; tenofovir disoproxil fumarate	TABLET;ORAL	211284-001	Nov 16, 2018		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma Ltd	LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	lamivudine; tenofovir disoproxil fumarate	TABLET;ORAL	022344-001	May 15, 2018		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan Labs Ltd	CIMDUO	lamivudine; tenofovir disoproxil fumarate	TABLET;ORAL	022141-001	Feb 28, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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