APPLICATION
ANDA208578
TYPE
ANDA
ORIGINAL APPROVAL
2017-02-24
LATEST ACTION
2025-03-03
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
OSELTAMIVIR PHOSPHATEPrescription
OSELTAMIVIR PHOSPHATE EQ 75MG BASE · CAPSULE · ORAL
OSELTAMIVIR PHOSPHATEPrescription
OSELTAMIVIR PHOSPHATE EQ 30MG BASE · CAPSULE · ORAL
OSELTAMIVIR PHOSPHATEPrescription
OSELTAMIVIR PHOSPHATE EQ 45MG BASE · CAPSULE · ORAL
Approval history
2025-03-03Labeling · Supplement 11 · standardAP
2025-03-03Labeling · Supplement 6 · standardAP
2025-03-03Labeling · Supplement 4 · standardAP
2025-03-03Labeling · Supplement 9 · standardAP
2025-03-03Labeling · Supplement 5 · standardAP
2017-02-24UNKNOWN · Original · 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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