← FDA DRUG APPROVALS

FDA NDA · NDA205040

RITONAVIR

Sponsor: CIPLA LIMITED

APPLICATION
NDA205040
TYPE
NDA
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)

Products

RITONAVIRNone (Tentative Approval)
RITONAVIR 50MG · TABLET · ORAL
RITONAVIRNone (Tentative Approval)
RITONAVIR 25MG · TABLET · ORAL

Approval history

2015-03-29Type 5 - New Formulation or New Manufacturer · Original · priority — Letter ↗TA
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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