NESHER PHARMS FDA Approval ANDA 208263

ANDA 208263

NESHER PHARMS

FDA Drug Application

Application #208263

Application Sponsors

ANDA 208263NESHER PHARMS

Marketing Status

Prescription001
Prescription002

Application Products

001CAPSULE;ORALEQ 50MG BASE0DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATE
002CAPSULE;ORALEQ 100MG BASE0DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATE

FDA Submissions

UNKNOWN; ORIG1AP2021-11-22STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

NESHER PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208263
            [companyName] => NESHER PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOXYCYCLINE HYCLATE","activeIngredients":"DOXYCYCLINE HYCLATE","strength":"EQ 50MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOXYCYCLINE HYCLATE","activeIngredients":"DOXYCYCLINE HYCLATE","strength":"EQ 100MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/22\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-11-22
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.