The product is a generic version of County Line Pharmaceuticals LLC's Fluocinonide Topical Solution USP, in the same strength, it added.
The product is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid- responsive dermatoses, it added.
The company's cumulative filings with the USFDA now stand at 368. It has received approvals for 219 products while 149 filings are pending approval.
Shares of Lupin were today trading 0.09 per cent higher at Rs 1,143.90 per scrip on BSE.