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FDA ANDA · ANDA208773

POSACONAZOLE

Sponsor: HIKMA

APPLICATION
ANDA208773
TYPE
ANDA
ORIGINAL APPROVAL
2020-05-15
LATEST ACTION
2024-10-24
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription

Products

POSACONAZOLEPrescription
POSACONAZOLE 40MG/ML · SUSPENSION · ORAL

Approval history

2024-10-24Labeling · Supplement 2 · standardAP
2024-10-24Labeling · Supplement 1 · standardAP
2020-05-15UNKNOWN · Original · standardLetterAP
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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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