The U.S. Food and Drug Administration (FDA) granted approval for a new generic drug application (ANDA 065394) for griseofulvin oral suspension.
The product, marketed by Actavis Pharma, Inc. and sponsored by ACTAVIS MID ATLANTIC, is a prescription‑only oral suspension containing 125 mg of griseofulvin per 5 mL. The dosage form is listed as a suspension with route of administration oral.
The submission was an original (ORIG) filing, submission number 1, and received an approved (AP) status on July 6, 2007. The product carries the NDC 0472‑0013‑04 and is classified as a human prescription drug.
Regulatory UpdatesSep 17, 2026•3 min read
FDA Approves Griseofulvin Oral Suspension (ANDA 065394)
The FDA has approved an oral suspension of griseofulvin (125 mg/5 mL) from Actavis Pharma under ANDA 065394.
Compiled by the Pharmacountry team · Source: FDA.gov
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