PARAGON BIOTECK FDA Approval NDA 213581

NDA 213581

PARAGON BIOTECK

FDA Drug Application

Application #213581

Documents

Letter2022-03-16
Label2022-03-16

Application Sponsors

NDA 213581PARAGON BIOTECK

Marketing Status

Prescription001

Application Products

001SOLUTION; OPHTHALMIC10MG/ML0ATROPINE SULFATEATROPINE SULFATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2022-03-15STANDARD

Submissions Property Types

ORIG1Null6

CDER Filings

PARAGON BIOTECK
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213581
            [companyName] => PARAGON BIOTECK
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATROPINE SULFATE","activeIngredients":"ATROPINE SULFATE","strength":"10MG\/ML","dosageForm":"SOLUTION; OPHTHALMIC","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"03\/15\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/213581s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/15\/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\\\/213581s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/213581Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-03-15
        )

)

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