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.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 060569 | CHARTWELL RX | 1971-09-09 | 2 |
| ANDA 061996 | CHARTWELL RX | 1982-04-06 | 6 |
| ANDA 065200 | CHARTWELL RX | 2005-03-02 | 1 |
| ANDA 065394 | ACTAVIS MID ATLANTIC | 2007-07-06 | 1 |
| ANDA 065354 | CIPLA | 2007-09-10 | 1 |
| ANDA 065438 | COSETTE PHARMS NC | 2010-10-08 | 1 |
| ANDA 202482 | SIGMAPHARM LABS LLC | 2012-10-22 | 1 |
| ANDA 202545 | SIGMAPHARM LABS LLC | 2012-10-22 | 2 |
| ANDA 091592 | SANDOZ | 2013-08-07 | 2 |
| ANDA 204371 | MOUNTAIN | 2014-01-09 | 2 |
| ANDA 202805 | SANDOZ | 2018-12-26 | 2 |
Official labeling on DailyMed
- ULTRAMICROSIZE GRISEOFULVIN (GRISEOFULVIN) TABLET [CHARTWELL RX, LLC.] · version 4 · 2025-12-12
- ULTRAMICROSIZE GRISEOFULVIN TABLET, COATED [SANDOZ INC] · version 8 · 2025-11-21
- GRISEOFULVIN TABLET [SANDOZ INC] · version 4 · 2025-11-21
- ULTRAMICROSIZE GRISEOFULVIN (GRISEOFULVIN) TABLET [HERITAGE PHARMACEUTICALS INC D/B/A AVET PHARMACEUTICALS INC] · version 3 · 2025-11-17
- GRISEOFULVIN MICROSIZE (GRISEOFULVIN) TABLET [HERITAGE PHARMACEUTICALS INC D/B/A AVET PHARMACEUTICALS INC] · version 2 · 2025-11-17
- GRISEOFULVIN SUSPENSION [ACTAVIS PHARMA, INC.] · version 17 · 2025-06-18
- ULTRAMICROSIZE GRISEOFULVIN TABLET [CHARTWELL RX, LLC] · version 1 · 2025-02-24
- ULTRAMICROSIZE GRISEOFULVIN TABLET [AYURAX, LLC.] · version 1 · 2025-02-05
- GRISEOFULVIN SUSPENSION [COSETTE PHARMACEUTICALS, INC.] · version 3 · 2024-12-04
- GRISEOFULVIN (GRISEOFULVIN (MICROSIZE)) SUSPENSION [CHARTWELL RX, LLC.] · version 3 · 2024-10-30
- GRISEOFULVIN MICROSIZE (GRISEOFULVIN) TABLET [CHARTWELL RX, LLC.] · version 3 · 2024-10-30
- GRISOFULVIN SUSPENSION [CIPLA USA INC.] · version 6 · 2024-03-28
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.