Overview
Saw palmetto is a plant/plant extract used in some OTC (over-the-counter) products. It is not an approved drug.
Indication
No indication information available.
Associated Conditions
- Dysuria
- Vitamin B complex deficiency
- Urination impaired
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2012/04/25 | Phase 1 | Completed | |||
2002/05/17 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| The Wellness Center | 50181-0030 | ORAL | 6 [hp_C] in 1 mL | 5/28/2025 | |
| Newton Laboratories, Inc. | 55714-4748 | ORAL | 15 [hp_X] in 1 mL | 8/20/2025 | |
| Apotheca Company | 57520-0494 | ORAL | 6 [hp_C] in 1 mL | 6/10/2025 |
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 |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| Honey Spring NAD+Men | 351666 | Medicine | A | 12/14/2020 | |
| Wanderlust Saw Palmetto | 380852 | Medicine | A | 12/15/2021 | |
| Vital Libido for Men | 418512 | Live Young Supplements Pty Ltd | Medicine | A | 8/18/2023 |
| Once a Day SAW PALMETTO Daily | 489036 | Medicine | A | 5/16/2025 | |
| Prostate Health Plus | 405692 | Medicine | A | 3/3/2023 | |
| HERBAL ENHANCER | 204945 | Pharma Botanica Pty Ltd | Medicine | A | 1/15/2013 |
| Facia Men | 330360 | Medicine | A | 2/25/2020 | |
| NZ SWISSE MEN'S ULTIVITE 50+ | 324280 | Medicine | A | 9/30/2019 | |
| Flouf Factor Growth Supplement | 477166 | Medicine | A | 1/30/2025 | |
| Prostate Plus | 406073 | Medicine | A | 3/10/2023 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| SABAL SERRULATA COMPOSÉ | dolisos canada inc. | 02236436 | Liquid
,
Granules
,
Globules - Oral | 3 CH | 1/5/1998 |
| HOMEOKNOP COMP-DROPS 10, DIURETIC | knop laboratories | 02242958 | Drops - Oral | 2 X / 30 ML | 11/10/2003 |
| PR NIX | terra botanica products ltd. | 02233358 | Liquid - Oral | 30 X | 5/25/1998 |
| RENTOX | bio active canada ltd. | 02233676 | Liquid - Oral | 3 X | 1/19/1998 |
| SABAL SERR GOUTTE 1DH-30CH | boiron laboratoires | 00670138 | Drops - Oral | 1 DH / DH | 12/31/1987 |
| RAW DEAL | kootenay born botanicals | 02232070 | Liquid - Oral | 30 X | 5/25/1998 |
| SABAL | bioforce canada inc. | 02231826 | Tablet
,
Liquid - Oral | 2 X | 2/11/1998 |
| ETHICAL HERBALS URINARY FLOW | ashbury research corporation | 02240739 | Capsule - Oral | 160 MG / CAP | N/A |
| SAW PALMETTO BERRIES 500MG | general nutrition canada inc. | 02240150 | Capsule - Oral | 500 MG | 12/17/1999 |
| SABAL SERULATA GOUTTE 4CH-30CH | dolisos laboratoires s.a. | 00684384 | Drops - Oral | 1 CH / CH | 12/31/1987 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
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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