NDA 214826

Almatica Pharma, LLC

FDA Drug Application

Application #214826

Documents

• Letter: 2021-08-31
• Review: 2022-06-29
• Letter: 2023-01-17
• Label: 2023-01-17
• Medication Guide: 2023-01-17
• Label: 2023-01-23

Application Sponsors

NDA 214826

Almatica Pharma, LLC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	CAPSULE, EXTENDED RELEASE;ORAL	1MG	0	LOREEV XR	LORAZEPAM
002	CAPSULE, EXTENDED RELEASE;ORAL	2MG	0	LOREEV XR	LORAZEPAM
003	CAPSULE, EXTENDED RELEASE; ORAL	3MG	0	LOREEV XR	LORAZEPAM
004	CAPSULE, EXTENDED RELEASE;ORAL	1.5MG	1	LOREEV XR	LORAZEPAM

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2021-08-27	STANDARD
LABELING; Labeling	SUPPL	3	AP	2023-01-13	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	6

CDER Filings

Almatica Pharma, LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214826
            [companyName] => Almatica Pharma, LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LOREEV XR","activeIngredients":"LORAZEPAM","strength":"1MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"LOREEV XR","activeIngredients":"LORAZEPAM","strength":"2MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"LOREEV XR","activeIngredients":"LORAZEPAM","strength":"3MG","dosageForm":"CAPSULE, EXTENDED RELEASE; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/27\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/214826Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-08-27
        )

)