NDAORALTABLET
Approved
Dec 1977
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
LIMBITROL (amitriptyline hydrochloride; chlordiazepoxide) by Molecular Devices is clinical pharmacology amitriptyline hydrochloride is an antidepressant with sedative effects. Approved for depression, anxiety, insomnia. First approved in 1977.
Drug data last refreshed 3d ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LIMBITROL is a fixed-dose combination tablet containing amitriptyline hydrochloride (tricyclic antidepressant) and chlordiazepoxide (benzodiazepine) approved in 1977. It treats depression, anxiety, and insomnia by potentiating norepinephrine and serotonin neurotransmission while providing anxiolytic and sedative effects. The combination addresses both mood disorders and anxiety-related sleep disturbance in a single oral formulation.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100); brand team likely focused on lifecycle extension or managed decline strategy.
Mechanism of Action
CLINICAL PHARMACOLOGY Amitriptyline hydrochloride is an antidepressant with sedative effects. Its mechanism of action in man is not known. It is not a monoamine oxidase inhibitor and it does not act primarily by stimulation of the central nervous system. Amitriptyline inhibits the membrane pump…
Indications (3)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.