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FDA NDA · NDA209847

DARUNAVIR AND RITONAVIR

Sponsor: MYLAN PHARMS INC

APPLICATION
NDA209847
TYPE
NDA
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

DARUNAVIR AND RITONAVIRPrescription
DARUNAVIR AND RITONAVIR 400MG/50MG · TABLET · ORAL

Approval history

2023-12-22Type 4 - New Combination · Original · priorityLetterTA
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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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