APPLICATION
ANDA075591
TYPE
ANDA
ORIGINAL APPROVAL
2001-05-10
LATEST ACTION
2024-08-20
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINERPrescription
FAMOTIDINE 0.4MG/ML · INJECTABLE · INJECTION
Approval history
2024-08-20Labeling · Supplement 12 · standardAP
2015-04-06Labeling · Supplement 7 · standardAP
2011-01-06Labeling · Supplement 3AP
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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