Data updated: Mar 10, 2026
ATROPINE SULFATE
ATROPINE SULFATE
Approved 1990-09-19
21
Indications
--
Phase 3 Trials
1
Priority Reviews
35
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1990-09-19
- Routes
- INHALATION, OPHTHALMIC, INTRAVENOUS, INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL
- Dosage Forms
- AEROSOL, METERED, SOLUTION/DROPS, SOLUTION
Companies
US ARMY AMNEAL SOMERSET THERAPS LLC ACCORD HLTHCARE Hikma Apotex Fresenius Kabi INTL MEDICATION SYS AM REGENT SOMERSET RISING MANKIND PHARMA BAUSCH AND LOMB INC MEDEFIL INC Pfizer
Active Ingredient: ATROPINE SULFATE
Website: ↗
ATROPINE SULFATE Approval History
Loading approval history...
What ATROPINE SULFATE Treats
21 FDA approvalsOriginally approved for its first indication in 1990 . Covers 21 distinct patient populations.
- Other (21)
Other
(21 approvals)- • Approved indication (Sep 1990)
- • Approved indication (Jul 2001)Label Letter
- • Approved indication (Jul 2014) PriorityLabel Letter
- • Approved indication (Jan 2018)Label Letter
- • Approved indication (Sep 2020)Label Letter
- • Approved indication (Oct 2020)Letter
- • Approved indication (Mar 2021)Letter
- • Approved indication (Jul 2021)Letter
- • Approved indication (Nov 2021)Letter
- • Approved indication (Dec 2021)
- • Approved indication (Jan 2022)Letter
- • Approved indication (Mar 2022)Label Letter
- • Approved indication (May 2022)Letter
- • Approved indication (Jul 2022)Letter
- • Approved indication (Nov 2022)
- • Approved indication (Jan 2024)
- • Approved indication (Apr 2024)Letter
- • Approved indication (Jul 2024)
- • Approved indication (Jul 2024)
- • Approved indication (Nov 2024)
- • Approved indication (Oct 2025) New
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
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 SULFATE FDA Label Details
ProWant competitive intelligence?
See who's developing similar drugs and track their progress
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.