Aurobindo Receives FDA Approval for Lidocaine Hydrochloride Oral Topical Solution USP, 2%
Published: July 29, 2025
East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Lidocaine Hydrochloride Oral Topical Solution USP, 2%. Aurobindo Pharma’s Lidocaine Hydrochloride Oral Topical Solution, are an AB-rated generic equivalent to the reference listed drug (RLD), Xylocaine Oral Topical Solution manufactured by Fresenius Kabi USA LLC.
Lidocaine Hydrochloride Oral Topical Solution are indicated for:
- Production of topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx.
- Useful for reducing gagging during the taking of X-ray pictures and dental impressions.
