Atropine Sulfate Injection

FDA Drug Profile — Atropine Sulfate

Drug Details

Generic Name
Atropine Sulfate Injection
Brand Names
Atropine Sulfate
Application Number
ANDA214970
Sponsor
ProPharma Distribution
NDC Codes
2
Dosage Forms
INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients
ATROPINE SULFATE

Shortage Status

Current

Discontinuation of the manufacture of the drug

Indications and Usage

1 INDICATIONS AND USAGE Atropine Sulfate Injection, USP, is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat bradyasystolic cardiac arrest. These highlights do not include all the information needed to use ATROPINE SULFATE INJECTION safely and effectively. See full prescribing information for ATROPINE SULFATE INJECTION. ATROPINE SULFATE injection, for intravenous use Initial U.S. Approval: 1960