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FDA NDA · NDA214826

LOREEV XR

lorazepam

Sponsor: ALMATICA

APPLICATION
NDA214826
TYPE
NDA
ORIGINAL APPROVAL
2021-08-27
LATEST ACTION
2023-01-13
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

LOREEV XR · ReferencePrescription
LORAZEPAM 3MG · CAPSULE, EXTENDED RELEASE · ORAL
LOREEV XR · ReferencePrescription
LORAZEPAM 1MG · CAPSULE, EXTENDED RELEASE · ORAL
LOREEV XR · ReferencePrescription
LORAZEPAM 1.5MG · CAPSULE, EXTENDED RELEASE · ORAL
LOREEV XR · ReferencePrescription
LORAZEPAM 2MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2023-01-13Labeling · Supplement 3 · standard — Letter ↗AP
2023-01-13Labeling · Supplement 1 · standardAP
2021-08-27Type 3 - New Dosage Form · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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