ATROPINE SULFATE · AM REGENT
ATROPINE SULFATE is FDA-approved to treat 3 conditions (same as ISOPTO ATROPINE).
Details
- Status
- Prescription
- First Approved
- 1960-09-15
- Routes
- INTRAVENOUS, INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL, OPHTHALMIC, INHALATION
- Dosage Forms
- SOLUTION, SOLUTION/DROPS, AEROSOL, METERED
Companies
ATROPINE SULFATE Approval History
What ATROPINE SULFATE Treats
3 indicationsATROPINE SULFATE is approved for 3 conditions since its original approval in 1990. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Mydriasis
- Cycloplegia
- Amblyopia
Same approved indications as ISOPTO ATROPINE (same active ingredient).
Clinical Trial Registry
10 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02858310 results posted | 160154 16-C-0154 | Ph 1, Ph 2 | completed | E7 TCR T Cells for Human Papillomavirus-Associated Cancers |
| NCT05470881 PRO-201 results posted | SOPH201-0521/I | Ph 1 | completed | Phase I Clinical Trial to Evaluate the Safety and Tolerability of Ophtalmic Solution PRO-201 |
| NCT06697522 | Protocol V 7.0 | Ph 3 | completed | Study of Atropine Sulfate Eye Drops(0.01%) in Treating Near-work-induced Transient Myopia in Children |
| NCT05481489 PRO-230 | SOPH230-1121/I | Ph 1 | withdrawn | Safety and Tolerability Evaluation of PRO-230 Ophthalmic Solution |
| NCT03690089 CHAMP-UK | 17097AB-AS 2017-004108-23 | Ph 2 | active not recruiting | Low-dose Atropine Eye Drops to Reduce Progression of Myopia in Children in the United Kingdom |
| NCT05372991 | CBT-CS201 | Ph 1, Ph 2 | completed | Safety, Tolerability and Pharmacodynamics Evaluation of CBT-009 Eye Drop |
| NCT03932578 | MSA10 | Ph 4 | completed | Intrathecal Atropine vs IV Metoclopramide for Nausea & Vomiting During CS |
| NCT01858090 | KA08/48 | Ph 3 | completed | Intrathecal Levobupivacaine With Opioids for Caesarean Section |
| NCT00947596 | PRO07030057 | Ph 1 | completed | A Study of Inhaled Atropine Sulfate in Healthy Adults |
| NCT06327399 | MS-373-2023 | Ph 2 | completed | Dexmedetomidine Infusion Dose Versus Rapid Bolus Dose Before Tracheal Intubation. |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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 SULFATE FDA Label Details
Indications & Usage
FDA Label (PDF)ATROPINE SULFATE is FDA-approved to treat 3 conditions — same approved indications as ISOPTO ATROPINE.
Looking for the branded version?
ISOPTO ATROPINE
Full clinical data, patents, trials, and competitive landscape for atropine sulfate.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.