Lithium

FDA Drug Profile — Lithium

Lithium is listed in the FDA National Drug Code directory with 7 NDC codes, marketed under brand name including Lithium. Available dosage form: solution.

Drug Details

Generic Name
Lithium
Brand Names
Lithium
Application Number
ANDA070755
Sponsor
PAI Holdings, LLC dba PAI Pharma
NDC Codes
7
Dosage Forms
SOLUTION
Routes
ORAL
Active Ingredients
LITHIUM CITRATE

Indications and Usage

1 INDICATIONS AND USAGE Lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder: • Treatment of acute manic and mixed episodes in patients 7 years and older [see Clinical Studies ( 14 )] • Maintenance treatment in patients 7 years and older [see Clinical Studies ( 14 )] Lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder: • Treatment of acute manic and mixed episodes in patients 7 years and older ( 1 ) • Maintenance treatment in patients 7 years and older ( 1 )