APPLICATION
ANDA075709
TYPE
ANDA
ORIGINAL APPROVAL
2001-04-16
LATEST ACTION
2020-09-15
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
FAMOTIDINEPrescription
FAMOTIDINE 10MG/ML · INJECTABLE · INJECTION
Approval history
2020-09-15Labeling · Supplement 10 · standardAP
2002-12-05Manufacturing (CMC) · Supplement 1AP
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.
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