APPLICATION
ANDA075486
TYPE
ANDA
ORIGINAL APPROVAL
2001-04-16
LATEST ACTION
2021-09-22
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
FAMOTIDINE PRESERVATIVE FREEPrescription
FAMOTIDINE 10MG/ML · INJECTABLE · INJECTION
Approval history
2021-09-22Labeling · Supplement 17 · standardAP
2008-05-20Labeling · Supplement 7AP
2002-11-08Manufacturing (CMC) · Supplement 2AP
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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