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Re: Zardiw post# 43083

Wednesday, 05/31/2023 11:21:41 AM

Wednesday, May 31, 2023 11:21:41 AM

Post# of 45199
Yes, they don't need to do a full NDA. They can submit a 505(b)(2) NDA to the FDA for approval of a new dronabinol label, as opposed to the submission and approval of a full 505(b)(1) NDA.
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