NDA 215428

ALMATICA

FDA Drug Application

Application #215428

Documents

• Letter: 2022-02-01
• Label: 2022-02-03
• Medication Guide: 2022-02-03
• Review: 2022-10-26

Application Sponsors

NDA 215428

ALMATICA

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE; ORAL

30MG

0

CITALOPRAM

CITALOPRAM

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient

ORIG

1

AP

2022-01-31

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

TBD

CDER Filings

ALMATICA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215428
            [companyName] => ALMATICA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CITALOPRAM","activeIngredients":"CITALOPRAM","strength":"30MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/31\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 2 - New Active Ingredient","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/215428Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-01-31
        )

)