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TAGAMET HB

TRACKED

CASHSN
THERAPEUTIC AREAS
MOLECULE INTELLIGENCE SNAPSHOTlive
14
Manufacturers monitored
38
Intelligence briefs
3
Active regulatory actions
₹2,800 Cr
Est. India export value

INTELLIGENCE

Showing 1 of 1 briefs for TAGAMET HB
CLINICAL & PIPELINE·Drug Approval

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.

90-Day Activity
MKMeera Krishnan· Senior Regulatory Intelligence Analyst
2020-04-13