ATROPINE SULFATE

Post-LOE

atropine sulfate

Hikma

ANDAINTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEALSOLUTION1 Generic Approved

Approved

Dec 2021

Lifecycle

Post-LOE

Competitive Pressure

45/100

Clinical Trials

Data completeness

4/8 — Partial

ATROPINE SULFATE (atropine sulfate) by Hikma is muscarine-like actions of acetylcholine and other choline esters. Approved for older for: atropine is an anticholinergic indicated in adults, older for: cycloplegia (1. First approved in 2021.

Drug data last refreshed 20h ago

Mechanism of Action

muscarine-like actions of acetylcholine and other choline esters. Atropine inhibits the muscarinic actions of acetylcholine on structures innervated by postganglionic cholinergic nerves, and on smooth muscles which respond to endogenous acetylcholine but are not so innervated. As with other…

Indications (2)

older for: Atropine is an anticholinergic indicated in adults

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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.

Clinical Trials (3)

NCT05855018Phase 1Unknown

A Study of Atropine Sulfate in Healthy Chinese Volunteers

Started May 2023

30 enrolled

Pharmacokinetics

NCT06209281Phase 3Active Not Recruiting

A Phase III Clinical Study of the Efficacy and Safety of Two Low-concentration Atropine Sulfate Eye Drops

Started May 2022

526 enrolled

Myopia

NCT06209320Phase 3Active Not Recruiting

A Study of the Efficacy and Safety of Two Low-concentration Atropine Sulfate Eye Drops

Started Mar 2022

777 enrolled

Myopia