Requests that the FDA refrain from receiving or approving any ANDA that references Imvexxy (estradiol vaginal inserts), NDA #208564, unless the shape of the vaginal insert is the same teardrop shape as that of Imvexxy.
🏛 Food and Drug Administration (FDA)FDA-2020-P-1334
Documents
0
Total comments
0
all analyzed
Comment status
Closed
Last activity
—
In this docket
Documents
Rules, notices, and supporting material — the primary rule pinned first.
No documents mirrored for this docket yet.