NDC 75834-0148-30
fluoxetine hydrochloride 60 mg/1 TABLET
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NDC
75834-0148-30
Generic Name
fluoxetine hydrochloride
Brand Name
fluoxetine
Strength
60 mg/1
Dosage Form
TABLET
Route
ORAL
Package Size
—
Labeler
NIVAGEN PHARMACEUTICALS, INC.
FDA Drug Information
Indications & Usage
1 INDICATIONS AND USAGE Fluoxetine tablets are indicated for the treatment of: Major Depressive Disorder (MDD). The efficacy of fluoxetine in MDD was established in one 5-week trial, three 6-week trials, and one maintenance study in adults. The efficacy of fluoxetine was also established in two 8- to 9-week trials in pediatric patients 8 to 18 years of age [see Clinical Studies ( 14.1 )]. Obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD). The efficacy of fluoxetine…
Source: FDA. For professional use only. Not a substitute for prescribing information.
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