PAR PHARM INC FDA Approval ANDA 202294

ANDA 202294

PAR PHARM INC

FDA Drug Application

Application #202294

Documents

Letter2017-04-21
Label2017-05-01
Pediatric CDTL Review1900-01-01
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01

Application Sponsors

ANDA 202294PAR PHARM INC

Marketing Status

Prescription001
Prescription002

Application Products

001CAPSULE, DELAYED RELEASE;ORAL60MG0DEXLANSOPRAZOLEDEXLANSOPRAZOLE
002CAPSULE, DELAYED RELEASE;ORAL30MG0DEXLANSOPRAZOLEDEXLANSOPRAZOLE

FDA Submissions

UNKNOWN; ORIG1AP2017-04-19
LABELING; LabelingSUPPL2AP2022-05-03STANDARD
LABELING; LabelingSUPPL3AP2022-05-03STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL6AP2022-06-16UNKNOWN
LABELING; LabelingSUPPL9AP2022-08-03STANDARD

Submissions Property Types

ORIG1Null15
SUPPL2Null7
SUPPL3Null15
SUPPL6Null7
SUPPL9Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

PAR PHARM INC
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(
    [0] => Array
        (
            [ApplNo] => 202294
            [companyName] => PAR PHARM INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXLANSOPRAZOLE","activeIngredients":"DEXLANSOPRAZOLE","strength":"60MG","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"04\/19\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/202294Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"04\/19\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/202294Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/202294Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"10\/01\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-10-01
        )

)

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