← FDA DRUG APPROVALS

FDA ANDA · ANDA075302

FAMOTIDINE

Sponsor: MANKIND PHARMA

APPLICATION
ANDA075302
TYPE
ANDA
ORIGINAL APPROVAL
2001-04-16
LATEST ACTION
2002-03-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

FAMOTIDINEPrescription
FAMOTIDINE 20MG · TABLET · ORAL
FAMOTIDINEPrescription
FAMOTIDINE 40MG · TABLET · ORAL

Approval history

2002-03-25Manufacturing (CMC) · Supplement 1AP
2001-04-16OriginalLetterAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →