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FDA NDA · NDA215428

CITALOPRAM

Sponsor: ALMATICA

APPLICATION
NDA215428
TYPE
NDA
ORIGINAL APPROVAL
2022-01-31
LATEST ACTION
2023-08-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

CITALOPRAM HYDROBROMIDE · ReferencePrescription
CITALOPRAM HYDROBROMIDE EQ 30MG BASE · CAPSULE · ORAL

Approval history

2023-08-18Labeling · Supplement 2 · standard — Label ↗AP
2022-01-31Type 2 - New Active Ingredient and Type 3 - New Dosage Form · Original · standard — Letter ↗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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