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Sold as Limbitrol, Limbitrol Ds. Every FDA application for this active ingredient: 1 branded and 11 generic.
As of Nov 15, 2026, FDA lists 12 applications for Amitriptyline Hydrochloride; Chlordiazepoxide (sold as Limbitrol, Limbitrol Ds), first approved Dec 23, 1977, with 0 new uses approved and 0 published complete response letters.
First approved: Dec 23, 1977
Applications: 12
New uses approved: 0
Complete response letters: 0
Applications
NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA