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Number sleven

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Number sleven

Re: DAR53 post# 436979

Thursday, 06/26/2025 4:34:55 PM

Thursday, June 26, 2025 4:34:55 PM

Post# of 447265
DAR53, Even though the active ingredient is the same, I believe the new formulation would still be a new drug requiring an NDA. I don't see why we would need to apply for the SHTG label. If someone has a better understanding please correct me.
Sleven,
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