APPLICATION
ANDA206043
TYPE
ANDA
ORIGINAL APPROVAL
2016-06-23
LATEST ACTION
2026-05-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PRIMAQUINE PHOSPHATEPrescription
PRIMAQUINE PHOSPHATE EQ 15MG BASE · TABLET · ORAL
Approval history
2026-05-07Labeling · Supplement 6 · standardAP
2026-05-07Labeling · Supplement 5 · standardAP
2023-06-12Labeling · Supplement 2 · standardAP
2023-06-12Labeling · Supplement 1 · standardAP
2016-06-23UNKNOWN · 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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