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Medtech Products — Tarrytown

Operated by Medtech Products · Tarrytown, NY
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Intelligence briefs

Regulatory Observation Log

CLINICAL & PIPELINEDrug Approval2020-04-13

Medtech Products' TAGAMET HB (Cimetidine) Secures Enduring Market Position Through Continuous FDA Approvals

Medtech Products' TAGAMET HB (Cimetidine) achieved a pivotal Type 8 Partial Rx to OTC Switch approval from the FDA on June 19, 1995. This strategic move established Cimetidine as a key over-the-counter histamine H2 receptor antagonist. Subsequent, continuous manufacturing (CMC) and labeling approvals, including a May 2022 update, underscore Medtech's commitment to regulatory compliance and supply chain stability, crucial for sustained market presence.

MK
Meera Krishnan
Senior Regulatory Intelligence Analyst