Overview
Fluoxetine is a 2nd generation antidepressant categorized as a selective serotonin reuptake inhibitor (SSRI). It gained FDA approval in 1987 and although it was initially intended for the treatment of depression, today it is commonly prescribed to manage depression in addition to various other pathologies.
Indication
Fluoxetine is indicated for both acute and maintenance treatment of major depressive disorder, obsessive compulsive disorder, and bulimia nervosa; however, it is only indicated for acute treatment of panic disorder independent of whether agoraphobia is present. Fluoxetine may also be used in combination with olanzapine to treat depression related to Bipolar I Disorder, and treatment resistant depression. Fluoxetine is additionally indicated for the treatment of female patients with premenstrual dysphoric disorder (PMDD).
Associated Conditions
- Alcohol Dependency
- Anorexia Nervosa (AN)
- Bulimia Nervosa
- Cataplexy
- Depression
- Major Depressive Disorder (MDD)
- Major depressive disorder, recurrent episode
- Myoclonus
- Obesity
- Obsessive Compulsive Disorder (OCD)
- Panic Disorder With Agoraphobia
- Panic disorder without agoraphobia
- Premature Ejaculation
- Premenstrual Dysphoric Disorder (PMDD)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/08/08 | Not Applicable | Not yet recruiting | |||
2025/06/05 | Phase 2 | Not yet recruiting | |||
2025/03/06 | Phase 3 | Recruiting | |||
2024/12/27 | Not Applicable | Completed | Zhifeng Zhao, PhD | ||
2024/07/17 | Phase 1 | Not yet recruiting | Zhifeng Zhao, PhD | ||
2024/04/25 | Not Applicable | Not yet recruiting | |||
2024/04/02 | Not Applicable | Completed | |||
2024/01/25 | Phase 1 | Recruiting | |||
2024/01/24 | N/A | Recruiting | Xijing Hospital of Digestive Diseases | ||
2023/12/29 | Not Applicable | Active, not recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| A-S Medication Solutions | 50090-6064 | ORAL | 40 mg in 1 1 | 9/22/2023 | |
| AvKARE | 42291-656 | ORAL | 50 mg in 1 1 | 1/10/2024 | |
| RedPharm Drug, Inc. | 67296-1690 | ORAL | 10 mg in 1 1 | 1/14/2021 | |
| Bryant Ranch Prepack | 63629-1609 | ORAL | 10 mg in 1 1 | 1/15/2024 | |
| Bryant Ranch Prepack | 71335-1145 | ORAL | 40 mg in 1 1 | 8/2/2022 | |
| Clinical Solutions Wholesale, LLC | 58118-0645 | ORAL | 20 mg in 1 1 | 10/24/2022 | |
| Teva Pharmaceuticals USA, Inc. | 50111-647 | ORAL | 10 mg in 1 1 | 8/15/2023 | |
| Physicians Total Care, Inc. | 54868-4562 | ORAL | 40 mg in 1 1 | 10/11/2010 | |
| Torrent Pharmaceuticals Limited | 13668-473 | ORAL | 20 mg in 1 1 | 5/31/2022 | |
| Cardinal Health 107, LLC | 55154-1341 | ORAL | 20 mg in 1 1 | 1/13/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| PROCTIN CAPSULE 20 mg | SIN11954P | CAPSULE | 20 mg | 5/25/2002 | |
| PROZAC CAPSULE 20 mg | SIN03027P | CAPSULE | 20 mg | 6/7/1989 | |
| FLUXIL CAPSULE 20 mg | SIN12576P | CAPSULE | 20 mg | 7/31/2004 | |
| FLUOXETINE-TEVA 20 MG CAPSULES | SIN12311P | CAPSULE | 20 mg | 6/5/2003 | |
| APO-FLUOXETINE CAPSULE 20 mg (Ivory/Green) | SIN09318P | CAPSULE | 20 mg | 5/2/1997 | |
| MAGRILAN CAPSULE 20 mg | SIN05766P | CAPSULE | 20 mg | 4/16/1991 | |
| FLUOXONE DIVULE TABLET 20 mg | SIN12214P | TABLET | 20 mg | 3/4/2003 | |
| APO-FLUOXETINE CAPSULE 10 mg (Grey/Green) | SIN09317P | CAPSULE | 10 mg | 5/2/1997 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| ZACTIN fluoxetine 20mg (as hydrochloride) capsule bottle | 53774 | Medicine | A | 11/13/1995 | |
| FLUOXETINE DISPERSIBLE TABLETS 20mg (AF) bulk | 97750 | Medicine | A | 10/23/2003 | |
| NOUMED FLUOXETINE fluoxetine (as hydrochloride) 20 mg capsule blister pack | 308455 | Medicine | A | 11/14/2018 | |
| FLUOXETINE (AS HYDROCHLORIDE) 60 mg (AF) capsule - hard bulk | 93447 | Medicine | A | 3/10/2003 | |
| FLUOXETINE 20 fluoxetine 20mg (as hydrochloride) capsule blister pack | 130619 | Medicine | A | 5/15/2007 | |
| Fluoxetine Dispersible Tablets 20mg blister pack | 133032 | Medicine | A | 11/16/2006 | |
| ZACTIN TABS fluoxetine hydrochloride 20mg dispersible tablet blister pack | 90913 | Medicine | A | 9/12/2002 | |
| FLUOXETINE MLABS 20mg fluoxetine (as hydrochloride) 20 mg capsules blister pack | 273922 | Medicine | A | 2/23/2017 | |
| FLUOXETINE-WGR 20mg fluoxetine (as hydrochloride) 20 mg capsules blister pack | 431494 | Medicine | A | 5/29/2024 | |
| FLUOXETINE GENERICHEALTH fluoxetine (as hydrochloride) 20 mg capsule blister pack | 146600 | Medicine | A | 10/21/2008 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| FLUOXETINA BENEL 20 mg CAPSULAS DURAS EFG | Farmalider S.A. | 62660 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| FLUOXETINA COMBIX 20 mg CAPSULAS DURAS EFG | Laboratorios Combix S.L.U. | 63679 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| FLUOXETINA MABO 20 mg CAPSULAS DURAS EFG | Mabo Farma S.A. | 63658 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| FLUOXETINA ARISTO 20 MG COMPRIMIDOS DISPERSABLES EFG | Aristo Pharma Iberia S.L. | 64944 | COMPRIMIDO DISPERSABLE | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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