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FDA ANDA · ANDA210187

DARUNAVIR ETHANOLATE

Sponsor: MICRO LABS USA

APPLICATION
ANDA210187
TYPE
ANDA
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)

Products

DARUNAVIR ETHANOLATENone (Tentative Approval)
DARUNAVIR ETHANOLATE 400MG · TABLET · ORAL
DARUNAVIR ETHANOLATENone (Tentative Approval)
DARUNAVIR ETHANOLATE 600MG · TABLET · ORAL
DARUNAVIR ETHANOLATENone (Tentative Approval)
DARUNAVIR ETHANOLATE 150MG · TABLET · ORAL

Approval history

2020-12-14UNKNOWN · Original · standardTA
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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