MedPath

Griseofulvin

Generic Name
Griseofulvin
Brand Names
Gris-peg
Drug Type
Small Molecule
Chemical Formula
C17H17ClO6
CAS Number
126-07-8
Unique Ingredient Identifier
32HRV3E3D5

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

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
© Copyright 2025. All Rights Reserved by MedPath