Overview
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 | 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 |
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