OTC ranitidine two-tablet effervescent dose subject of ANDA suitability petition.
This article was originally published in The Tan Sheet
Executive Summary
OTC RANITIDINE TWO-TABLET EFFERVESCENT DOSE containing 37.5 mg of the H2 antagonist ingredient per tablet is the subject of a Sept. 3 ANDA suitability petition filed with FDA on behalf of an unnamed company. The two-tablet dose of the acid blocker would differ from a one-tablet 75 mg dose of Warner-Lambert's Zantac 75 in "dosage form and amount of active ingredient per tablet," Thomas Blake, a Budd Lake, N.J.-based regulatory strategist, says in the petition.