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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.
FDA
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FTC Seek Comments on Generic Clearance for Service Delivery, Paperwork Reduction Act Comment, OMB No. 3084-0159
FTC
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