NDA 213593

AZURITY PAHRMACEUTICALS, INC

FDA Drug Application

Application #213593

Documents

• Letter: 2022-09-01
• Label: 2022-08-31
• Medication Guide: 2022-08-31

Application Sponsors

NDA 213593

AZURITY PAHRMACEUTICALS, INC

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ORAL

2MG; 84MG / ML

0

KONVOMEP

OMEPRAZOLE AND SODIUM BICARBONATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2022-08-30

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

AZURITY PAHRMACEUTICALS, INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213593
            [companyName] => AZURITY PAHRMACEUTICALS, INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/213593s000lbl.pdf#page=28"]
            [products] => [{"drugName":"KONVOMEP","activeIngredients":"OMEPRAZOLE AND SODIUM BICARBONATE","strength":"2MG; 84MG \/ ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"08\/30\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/213593s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/30\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/213593s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/213593Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-08-30
        )

)