LANNETT CO INC FDA Approval ANDA 212997

ANDA 212997

LANNETT CO INC

FDA Drug Application

Application #212997

Application Sponsors

ANDA 212997LANNETT CO INC

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005

Application Products

001CAPSULE;ORALEQ 10MG BASE0DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDE
002CAPSULE;ORALEQ 25MG BASE0DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDE
003CAPSULE;ORALEQ 50MG BASE0DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDE
004CAPSULE;ORALEQ 75MG BASE0DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDE
005CAPSULE;ORALEQ 100MG BASE0DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-07-24STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB
005PrescriptionAB

CDER Filings

LANNETT CO INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212997
            [companyName] => LANNETT CO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOXEPIN HYDROCHLORIDE","activeIngredients":"DOXEPIN HYDROCHLORIDE","strength":"EQ 10MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOXEPIN HYDROCHLORIDE","activeIngredients":"DOXEPIN HYDROCHLORIDE","strength":"EQ 25MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOXEPIN HYDROCHLORIDE","activeIngredients":"DOXEPIN HYDROCHLORIDE","strength":"EQ 50MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOXEPIN HYDROCHLORIDE","activeIngredients":"DOXEPIN HYDROCHLORIDE","strength":"EQ 75MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOXEPIN HYDROCHLORIDE","activeIngredients":"DOXEPIN HYDROCHLORIDE","strength":"EQ 100MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DOXEPIN HYDROCHLORIDE","submission":"DOXEPIN HYDROCHLORIDE","actionType":"EQ 10MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DOXEPIN HYDROCHLORIDE","submission":"DOXEPIN HYDROCHLORIDE","actionType":"EQ 25MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DOXEPIN HYDROCHLORIDE","submission":"DOXEPIN HYDROCHLORIDE","actionType":"EQ 50MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DOXEPIN HYDROCHLORIDE","submission":"DOXEPIN HYDROCHLORIDE","actionType":"EQ 75MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DOXEPIN HYDROCHLORIDE","submission":"DOXEPIN HYDROCHLORIDE","actionType":"EQ 100MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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