Overview
An antifungal antibiotic. Griseofulvin may be given by mouth in the treatment of tinea infections.
Background
An antifungal antibiotic. Griseofulvin may be given by mouth in the treatment of tinea infections.
Indication
For the treatment of ringworm infections of the skin, hair, and nails, namely: tinea corporis, tinea pedis, tinea cruris, tinea barbae, cradle cap or other conditions caused by Trichophyton or Microsporum fungi.
Associated Conditions
- Tinea Capitis
- Tinea Corporis
- Tinea Cruris
- Tinea Pedis
- Tinea Unguium
- Tinea barbae
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2020/03/24 | Phase 1 | Completed | |||
2012/01/25 | Phase 1 | Completed | |||
2009/03/18 | Phase 1 | Completed | |||
2009/03/18 | Phase 1 | Completed | |||
2005/07/08 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc | 23155-864 | ORAL | 250 mg in 1 1 | 8/9/2023 | |
| Chartwell RX, LLC. | 62135-494 | ORAL | 125 mg in 1 1 | 10/5/2023 | |
| Actavis Pharma, Inc. | 0472-0013 | ORAL | 125 mg in 5 mL | 10/6/2023 | |
| Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc | 23155-863 | ORAL | 125 mg in 1 1 | 8/9/2023 | |
| Sigmapharm Laboratories, LLC | 42794-013 | ORAL | 125 mg in 1 1 | 1/14/2022 | |
| Rebel Distributors Corp | 42254-306 | ORAL | 125 mg in 5 mL | 7/27/2010 | |
| Sandoz Inc | 0781-5515 | ORAL | 500 mg in 1 1 | 12/20/2016 | |
| Sigmapharm Laboratories, LLC | 42794-014 | ORAL | 250 mg in 1 1 | 1/14/2022 | |
| Chartwell RX, LLC. | 62135-495 | ORAL | 250 mg in 1 1 | 10/5/2023 | |
| Physicians Total Care, Inc. | 54868-5234 | ORAL | 125 mg in 5 mL | 10/25/2010 |
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 |
|---|---|---|---|---|---|
| HOVID-GRISEOFULVIN 500 TABLET B.P. 500mg | SIN07993P | TABLET, FILM COATED | 500.00 mg | 2/2/1995 | |
| HEXENE TABLET 125 mg | SIN00896P | TABLET | 125 mg | 5/9/1988 | |
| HEXENE-FORTE TABLET 500 mg | SIN00899P | TABLET | 500 mg | 5/9/1988 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Griseofulvin Capsules | 国药准字H15020511 | 化学药品 | 胶囊剂 | 5/14/2020 | |
| Griseofulvin Tablets | 国药准字H14020149 | 化学药品 | 片剂 | 8/3/2020 | |
| Griseofulvin Tablets | 国药准字H14020948 | 化学药品 | 片剂 | 4/10/2020 | |
| Griseofulvin Tablets | 国药准字H42021887 | 化学药品 | 片剂 | 6/10/2020 | |
| Griseofulvin Tablets | 国药准字H45020874 | 化学药品 | 片剂 | 9/20/2020 | |
| Griseofulvin Tablets | 国药准字H51022001 | 化学药品 | 片剂 | 12/18/2020 | |
| Griseofulvin Tablets | 国药准字H41025032 | 化学药品 | 片剂 | 7/23/2020 | |
| Griseofulvin Tablets | 国药准字H53020537 | 化学药品 | 片剂 | 10/10/2020 | |
| Griseofulvin Tablets | 国药准字H42021532 | 化学药品 | 片剂 | 6/17/2020 | |
| Griseofulvin Tablets | 国药准字H13020056 | 化学药品 | 片剂 | 9/20/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| FUYOU TAB 500MG | N/A | wilcome pharmaceutical co ltd | N/A | N/A | 2/15/1986 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| GRISOVIN griseofulvin 125 mg tablet bottle | 12512 | Medicine | A | 8/13/1991 | |
| GRISOVIN griseofulvin 500 mg tablet blister pack | 157849 | Medicine | A | 3/19/2009 |