← FDA DRUG APPROVALS

FDA ANDA · ANDA077553

TERCONAZOLE

Sponsor: SUN PHARMA CANADA

APPLICATION
ANDA077553
TYPE
ANDA
ORIGINAL APPROVAL
2007-03-09
LATEST ACTION
2016-02-23
ROUTE
VAGINAL
DOSAGE FORM
SUPPOSITORY
MARKETING STATUS
Prescription

Products

TERCONAZOLEPrescription
TERCONAZOLE 80MG · SUPPOSITORY · VAGINAL

Approval history

2016-02-23Labeling · Supplement 5 · standardAP
2016-02-23Labeling · Supplement 4 · standardAP
2007-03-09Original — Review ↗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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