TheraRadar
Data updated: May 26, 2026

ATROPINE SULFATE

Other Approved 1990-09-19
Jump to: Indications Approvals Trials Competitors Safety Patents
22
Indications
--
Phase 3 Trials
1
Priority Reviews
35
Years on Market

Details

Status
Discontinued
First Approved
1990-09-19
Routes
INHALATION, OPHTHALMIC, INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL, INTRAVENOUS
Dosage Forms
AEROSOL, METERED, SOLUTION/DROPS, SOLUTION

Companies

US ARMY BAUSCH AND LOMB INC Hikma SOMERSET THERAPS LLC SOMERSET EDENBRIDGE PHARMS ACCORD HLTHCARE MANKIND PHARMA INTL MEDICATION SYS AMNEAL RISING Fresenius Kabi Apotex MEDEFIL INC AM REGENT Pfizer
Active Ingredient: ATROPINE SULFATE

ATROPINE SULFATE Approval History

1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
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2014
2015
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2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
73 FDA actions from 1990 to 2026
May 2026 SUPPL
Label · Labeling
Apr 2026 ORIGINAL
Update
Mar 2026 SUPPL
Label · Labeling

What ATROPINE SULFATE Treats

22 FDA approvals

Originally approved for its first indication in 1990 . Covers 22 distinct patient populations.

  • Other (22)
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Clinical Trial Registry

9 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NCT05481489 PRO-230 SOPH230-1121/I Ph 1 withdrawn Safety and Tolerability Evaluation of PRO-230 Ophthalmic Solution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
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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

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MOTOFEN

Full clinical data, patents, trials, and competitive landscape for atropine sulfate.

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Data Sources

FDA Approval: NDA020056 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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