The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a revised draft guidance for industry on generic cyclobenzaprine hydrochloride extended release capsules, entitled ``Draft Guidance on Cyclobenzaprine Hydrochloride.'' The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for cyclobenzaprine hydrochloride extended release capsules.
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Bioequivalence Recommendations for Cyclobenzaprine Hydrochloride; Revised Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a revised draft guidance for industry on generic cyclobenzaprine hydrochloride extend...
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81 FR 85229
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“Bioequivalence Recommendations for Cyclobenzaprine Hydrochloride; Revised Draft Guidance for Industry; Availability,” thefederalregister.org (November 25, 2016), https://thefederalregister.org/documents/2016-28334/bioequivalence-recommendations-for-cyclobenzaprine-hydrochloride-revised-draft-guidance-for-industry-availability.