For Obsessive Compulsive Disorder (OCD). ANDA 211632, held by Lupin. Fluoxetine Hydrochloride.
As of Nov 15, 2026, ANDA 211632 (Fluoxetine Hydrochloride), held by Lupin, was first approved by FDA on Feb 8, 2019, with 2 approved supplements and 0 published complete response letters.
Fluoxetine Tablets is 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. Obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD). The efficacy of fluoxetine 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 |
|---|---|---|---|
| Feb 8, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fluoxetine HydrochlorideEQ 60MG BASE · tablet;oral | Fluoxetine Hydrochloride | Discontinued |
| Jan 3, 2024 | Supplement 4Labeling · Standard review | Approved | None posted |
| Jan 3, 2024 | Supplement 5Labeling · Standard review | Approved | None posted |
| Feb 8, 2019 | Original application | Approved | None posted |
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
