← FDA DRUG APPROVALS

FDA NDA · NDA021961

SIMVASTATIN

Sponsor: SYNTHON PHARMS

APPLICATION
NDA021961
TYPE
NDA
ORIGINAL APPROVAL
2007-10-09
LATEST ACTION
2007-10-09
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Discontinued

Products

SIMVASTATIN · ReferenceDiscontinued
SIMVASTATIN 40MG · TABLET, ORALLY DISINTEGRATING · ORAL
SIMVASTATIN · ReferenceDiscontinued
SIMVASTATIN 10MG · TABLET, ORALLY DISINTEGRATING · ORAL
SIMVASTATIN · ReferenceDiscontinued
SIMVASTATIN 80MG · TABLET, ORALLY DISINTEGRATING · ORAL
SIMVASTATIN · ReferenceDiscontinued
SIMVASTATIN 20MG · TABLET, ORALLY DISINTEGRATING · ORAL

Approval history

2007-10-09Type 3 - New Dosage Form · Original · standard — Label ↗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.

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