Request that the FDA take the following three actions described below: 1. Refuse to approve the Glenmark generic topical clobetasol propionate product submitted under ANDA 214191, and any similarly formulated generic products, because there is a reasonable basis to conclude that Glenmark made formulation changes, including significant changes to the vehicle, that likely increase absorption
🏛 Food and Drug Administration (FDA)FDA-2020-P-2212
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