Nonrulemaking

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

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.

© 2026 Government Context · not affiliated with any U.S. government agencyPrivacyTermsDockets