← FDA DRUG APPROVALS

FDA ANDA · ANDA078735

SIMVASTATIN

Sponsor: OXFORD PHARMS

APPLICATION
ANDA078735
TYPE
ANDA
ORIGINAL APPROVAL
2010-08-30
LATEST ACTION
2010-08-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

SIMVASTATINPrescription
SIMVASTATIN 80MG · TABLET · ORAL
SIMVASTATINPrescription
SIMVASTATIN 20MG · TABLET · ORAL
SIMVASTATINPrescription
SIMVASTATIN 5MG · TABLET · ORAL
SIMVASTATINPrescription
SIMVASTATIN 40MG · TABLET · ORAL
SIMVASTATINPrescription
SIMVASTATIN 10MG · TABLET · ORAL

Approval history

2010-08-30Original — Other Important Information from FDA ↗AP
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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →