For Obsessive Compulsive Disorder (OCD). ANDA 212683, held by Strides Pharma. Fluoxetine Hydrochloride.
As of Nov 15, 2026, ANDA 212683 (Fluoxetine Hydrochloride), held by Strides Pharma, was first approved by FDA on Sep 13, 2024, with 0 approved supplements and 0 published complete response letters.
Fluoxetine tablets are indicated for the treatment of: Major Depressive Disorder (MDD). The efficacy of fluoxetine tablets in MDD was established in one 5-week trial, three 6-week trials, and one maintenance study in adults. The efficacy of fluoxetine tablets was also established in two 8- to 9-week trials in pediatric patients 8 to 18 years of age. Obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD). The efficacy of fluoxetine tablets in OCD was demonstrated in two 13-week trials in adults and one 13-week trial in pediatric patients 7 to 17 years of age. Binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 13, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fluoxetine HydrochlorideEQ 60MG BASE · tablet;oral | Fluoxetine Hydrochloride | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
