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Active ingredient

Griseofulvin

21 finished FDA listings contain Griseofulvin as their only active ingredient.

FDA NDC Directory

Ingredient names as written by FDA
GRISEOFULVIN
Dosage forms
Suspension, Tablet, Tablet, Coated
Routes
Oral
Manufacturers / labelers
10
Strengths listed
125 mg/1 · 125 mg/5ml · 165 mg/1 · 250 mg/1 · 500 mg/1
Brand names in FDA listings
Griseofulvin, Griseofulvin Microsize, Ultramicrosize Griseofulvin

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 5021

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
ANDA 060569CHARTWELL RX1971-09-092
ANDA 061996CHARTWELL RX1982-04-066
ANDA 065200CHARTWELL RX2005-03-021
ANDA 065394ACTAVIS MID ATLANTIC2007-07-061
ANDA 065354CIPLA2007-09-101
ANDA 065438COSETTE PHARMS NC2010-10-081
ANDA 202482SIGMAPHARM LABS LLC2012-10-221
ANDA 202545SIGMAPHARM LABS LLC2012-10-222
ANDA 091592SANDOZ2013-08-072
ANDA 204371MOUNTAIN2014-01-092
ANDA 202805SANDOZ2018-12-262

Official labeling on DailyMed

Showing the 12 most recent of 14 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.