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Treats amblyopia 1.1 Mydriasis 1.2 Cycloplegia 1.3 Penalization of the healthy eye in the…. Sold as Atropine Sulfate, Isopto Atropine. Every FDA application for this active ingredient: 7 branded and 18 generic.
As of Nov 15, 2026, FDA lists 25 applications for Atropine Sulfate (sold as Atropine Sulfate, Isopto Atropine), first approved Sep 19, 1990, with 0 new uses approved and 0 published complete response letters.
First approved: Sep 19, 1990
Applications: 25
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $202K
First approved in the EU: Jun 2, 2025
Shortage: Current
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
Atropine Sulfate
Part B
$186K
+1%
8,376
ATROPINE SULFATE(J0462)
Part B
$15K
New
1,031
What Pharmacies Pay
Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change
ATROPINE 1% EYE DROP: $4.64 per MLGeneric · -19% in a year
ATROPINE 1% EYE DROPS: $7.37 per MLGeneric · -20% in a year
Approvals in the EU (EMA)
First approved in the EU 416 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
Alcon Labs Inc
Fresenius Kabi USA
Accord Hlthcare
Apotex
Hikma