TheraRadar
Data updated: May 26, 2026

ATROPINE (AUTOINJECTOR) (atropine)

Other Approved 2018-07-09
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
1
Priority Reviews
7
Years on Market

Details

Status
Discontinued
First Approved
2018-07-09
Routes
INTRAMUSCULAR
Dosage Forms
SOLUTION

Companies

RAFA LABS LTD
Active Ingredient: ATROPINE

ATROPINE (AUTOINJECTOR) Approval History

2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
3 FDA actions from 2018 to 2023
Feb 2023 SUPPL
Label · Labeling
FDA Letter Label
Jul 2019 SUPPL
Label · Labeling
FDA Letter Label
Jul 2018 ORIGINAL Priority
Update · Type 5 - New Formulation or New Manufacturer
Label

What ATROPINE (AUTOINJECTOR) Treats

1 FDA approvals

Originally approved for its first indication in 2018 .

  • Other (1)
📋

Clinical Trial Registry

23 trials
Trial Sponsor ID Phase Status Title
NCT07095894 MTS2 Ph 3 not yet recruiting A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control
NCT07367178 SATROPIN MEDOPP824 2025-524109-33-00 Ph 2 not yet recruiting Study of Sacituzumab Govitecan With Atropine to Improve Tolerability in Advanced TNBC and HR+/HER2- Breast Cancer
NCT06579287 SHJ002-MY201 Ph 2 active not recruiting A Study of SHJ002 Sterile Ophthalmic Solution for Myopia Control
NCT05815784 2022-5570 Ph 2 recruiting Myopia Control: a Comparison Study Between Atropine and MiSight
NCT06111352 OPC 59.18.1100.031.18.011.22.2268 Ph 2 completed Outcome of Moderate Severity in OPC Poisoning Patients When Treated With Pralidoxime
NCT03334253 MTS1 results posted MTS1 2U10EY011751 Ph 3 completed Low-Dose Atropine for Treatment of Myopia
NCT05658380 R216/2022 Ph 3 completed Impact of Pre-spinal Atropine on Post Spinal Hemodynamics and Cardiac Output Measured by Electrical Cardiometry in Caesarean Delivery
NCT01819064 results posted Atropine in infants Ph 4 completed Heart Rate Response to Atropine Doses Less Than 0.1mg IV to Anesthetized Infants
NCT02870478 IND 128961 Ph 3 completed The Effects of Low Concentration Atropine on Pupil Size and Accommodation
NCT02839668 TIVA/TCI-BC IuliuHatieganu Cluj-Napoca Ph 2 completed The Impact of Intravenous Anaesthesia on Angiogenesis in Patients With Breast Cancer (TIVA/TCI-BC)
NCT00944710 ATS16 results posted NEI-144 2U10EY011751 Ph 3 completed Augmenting Atropine Treatment for Amblyopia in Children 3 to < 8 Years Old
NCT03544827 1168531-2 Ph 4 completed The Effects of Low Dose Atropine on Choroidal Thickness
NCT02327923 IERB/284/014 Ph 4 completed Intraoperative Lidocaine Infusion vs. Esmolol Infusion for Postoperative Analgesia in Laparoscopic Cholecystectomy
NCT01845636 results posted 6577 W81XWH-12-0142 Ph 4 completed Olfactory Deficits in MCI as Predictor of Improved Cognition on Donepezil
NCT00724932 results posted P05699 19.4.318, MK-8616-002 Ph 3 completed Comparison of Sugammadex With Neostigmine During Laparoscopic Cholecystectomy or Appendectomy (P05699)
NCT02445599 DEOEC RKEB/IKEB 4044-2013 Ph 4 completed Diclofenac Premedication, as the Effect of Preemptive Analgesia After Post-thoracotomy Chest and Shoulder Pain
NCT02361060 PRIN-SUGAR-2014 Ph 4 completed Effects of Neuromuscular Block Reversal With Sugammadex vs Neostigmine on Postoperative Respiratory Outcomes After Major Abdominal Surgery
NCT02622126 IRB0000871175 Ph 2 completed Colloid Pre-Loading on D-Dimer During Cesarean Section Under Spinal Anesthesia
NCT02704923 CAAE 40374815.3.0000.5342 Ph 2 completed Atropine for Preventing Ventilator-Associated Pneumonia
NCT02658721 IVRA Ph 3 completed Effects of Systemic or Adjunct Tramadol Addition to Lidocaine Used for IVRA in Patients Undergoing Hand Surgery
NCT02522858 IIT-2015-101 Ph 4 completed Anticholinergic Premedication for Sedation With Dexmedetomidine During Spinal Anesthesia
NCT00834470 Atropine-01 Ph 4 completed Adjunctive Atropine During Ketamine Sedation
NCT00991627 ANEST-OST-02 Ph 4 completed Different Approaches to Maternal Hypotension During Cesarean Section
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

|
Loading...
Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

ATROPINE (AUTOINJECTOR) FDA Label Details

Track ATROPINE (AUTOINJECTOR) with TheraRadar Pro

Watchlist alerts, full database access, CSV exports across 14,000+ drugs.

Upgrade to Pro

Data Sources

FDA Approval: NDA212319 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.