NDC 0065-0303

Isopto Atropine 10 mg per 1 mL solution

On the label: Alcon Laboratories, Inc..

Germany: 1

Where it's made

FactoryWhereRoleLast FDA inspection
Boehringer Ingelheim Pharma GmbH and Co. KGIngelheim am Rhein, GermanyMakes the active ingredient and tests it Problems found, fixed voluntarilyMay 15, 2025 · 8 inspections, 1 with FDA action

Recalls

Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.

Product details

Generic drug
Atropine: every company that makes it
Form
solution, ophthalmic
Strength
10 mg per 1 mL
Approval
NDA NDA208151
On the market since
Aug 1, 2018
Package NDCs
0065-0303-55
Official label
DailyMed (National Library of Medicine), updated Oct 7, 2022

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