The product is generic version of Concordia Pharmaceuticals Inc's Plaquenil tablets in the same strength, it added.
Hydroxychloroquine tablets are used for treatment of certain type of malaria. It is also used, usually with other medications, to treat certain autoimmune diseases (lupus, rheumatoid arthritis) when other medications have not worked or cannot be used, Laurus Labs said.
"The company has also received a tentative approval for an abbreviated new drug application (ANDA) for Abacavir, Dolutegravir, and Lamivudine, tablets 600 mg/50 mg/300 mg from USFDA," it added.
The products will be commercialised from the company's manufacturing site located at Atchutapuram in Visakhapatnam, the company said.
Shares of Laurus Labs closed at Rs 363.85 per scrip on BSE, up 3.93 per cent from its previous close.
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