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Just the facts maam

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Just the facts maam

Re: None

Friday, 09/15/2023 5:23:38 PM

Friday, September 15, 2023 5:23:38 PM

Post# of 14914
According to the the most recent FDA supplemental approval, it looks like ANIP's Trademark "Sovuna" will be used for hydroxychloroquine sulfate.

Dear Muthusamy Shanmugam:
Please refer to your supplemental new drug application (sNDA) dated and received March 15, 2023, and your June 22 and August 16, 2023, amendments, pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Sovuna (hydroxychloroquine sulfate), 200mg and 300mg tablets.

This Prior Approval sNDA provides for inclusion of the proprietary name “Sovuna” in the prescribing information and container label.



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