APPLICATION
ANDA209113
TYPE
ANDA
ORIGINAL APPROVAL
2017-09-14
LATEST ACTION
2023-07-03
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Prescription
Products
OSELTAMIVIR PHOSPHATEPrescription
OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML · FOR SUSPENSION · ORAL
Approval history
2023-07-03Labeling · Supplement 12 · standardAP
2023-07-03Labeling · Supplement 10 · standardAP
2019-12-03Labeling · Supplement 2 · standardAP
2019-12-03Labeling · Supplement 5 · standardAP
2019-12-03Labeling · Supplement 3 · standardAP
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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