Requests that the FDA refrain from approving any ANDA submitted pursuant to an approved suitability petition under section 505(j)(2)(C) of the FD&C Act for dabrafenib mesylate capsules, 150 mg (EQ Base), unless and until the applicant has conducted and submitted to the FDA.
🏛 Food and Drug Administration (FDA)FDA-2026-P-6541
Documents
24
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0
all analyzed
Comment status
Open
Last activity
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In this docket
Documents
Rules, notices, and supporting material — the primary rule pinned first.
📄 Primary document
- Other· Jun 9, 2026No comment period
- Supporting & Related Material· Jun 9, 2026
- Supporting & Related Material· Jun 9, 2026
- Supporting & Related Material· Jun 9, 2026
- Supporting & Related Material· Jun 9, 2026
- Supporting & Related Material· Jun 9, 2026
- Supporting & Related Material· Jun 9, 2026
- Supporting & Related Material· Jun 9, 2026
- Supporting & Related Material· Jun 9, 2026
- Supporting & Related Material· Jun 9, 2026
- Supporting & Related Material· Jun 9, 2026
- Supporting & Related Material· Jun 9, 2026
- Supporting & Related Material· Jun 9, 2026
- Supporting & Related Material· Jun 9, 2026
- Supporting & Related Material· Jun 9, 2026
- Supporting & Related Material· Jun 9, 2026
- Supporting & Related Material· Jun 9, 2026
- Supporting & Related Material· Jun 9, 2026
- Supporting & Related Material· Jun 9, 2026
- Supporting & Related Material· Jun 9, 2026
- Supporting & Related Material· Jun 9, 2026
- Supporting & Related Material· Jun 9, 2026
- Supporting & Related Material· Jun 9, 2026
