Aurobindo Receives FDA Approval for Loperamide Hydrochloride Capsules USP 2mg
Published: September 06, 2023
East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Loperamide Hydrochloride Capsules USP, 2mg. Aurobindo Pharma’s Loperamide Hydrochloride Capsules are an AB-rated generic equivalent to the reference listed drug (RLD), Imodium® Capsules, manufactured by Johnson and Johnson Consumer Inc., McNeil Consumer Healthcare Division.
Loperamide Hydrochloride Capsules are indicated for :
- The control and symptomatic relief of acute nonspecific diarrhea in patients 2 years of age and older and of chronic diarrhea in adults associated with inflammatory bowel disease.
- Reducing the volume of discharge from ileostomies.