Atropine Sulfate monohydrate

FDA Drug Profile — Atropine Sulfate

Drug Details

Generic Name
Atropine Sulfate monohydrate
Brand Names
Atropine Sulfate
Application Number
ANDA215005
Sponsor
Somerset Therapeutics, LLC
NDC Codes
2
Dosage Forms
SOLUTION
Routes
ENDOTRACHEAL, INTRAMEDULLARY, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Active Ingredients
ATROPINE SULFATE

Indications and Usage

1 INDICATIONS AND USAGE Atropine sulfate ophthalmic solution 1% is indicated for: Atropine sulfate ophthalmic solution 1% is a muscarinic antagonist indicated for: Mydriasis (1.1) Cycloplegia (1.2) Penalization of the healthy eye in the treatment of amblyopia (1.3) 1.1 Mydriasis 1.2 Cycloplegia 1.3 Penalization of the healthy eye in the treatment of amblyopia