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FDA ANDA · ANDA078032

ESCITALOPRAM

Sponsor: PRINSTON INC

APPLICATION
ANDA078032
TYPE
ANDA
ORIGINAL APPROVAL
2015-08-28
LATEST ACTION
2025-03-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ESCITALOPRAM OXALATEPrescription
ESCITALOPRAM OXALATE EQ 10MG BASE · TABLET · ORAL
ESCITALOPRAM OXALATEPrescription
ESCITALOPRAM OXALATE EQ 20MG BASE · TABLET · ORAL
ESCITALOPRAM OXALATEPrescription
ESCITALOPRAM OXALATE EQ 5MG BASE · TABLET · ORAL

Approval history

2025-03-05Manufacturing (CMC) · Supplement 15 · unknownAP
2015-08-28Original — 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.

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