MAYNE PHARMA FDA Approval ANDA 206329

ANDA 206329

MAYNE PHARMA

FDA Drug Application

Application #206329

Application Sponsors

ANDA 206329MAYNE PHARMA

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005
Prescription006

Application Products

001TABLET;BUCCAL, SUBLINGUALEQ 0.1MG BASE0FENTANYL CITRATEFENTANYL CITRATE
002TABLET;BUCCAL, SUBLINGUALEQ 0.2MG BASE0FENTANYL CITRATEFENTANYL CITRATE
003TABLET;BUCCAL, SUBLINGUALEQ 0.3MG BASE0FENTANYL CITRATEFENTANYL CITRATE
004TABLET;BUCCAL, SUBLINGUALEQ 0.4MG BASE0FENTANYL CITRATEFENTANYL CITRATE
005TABLET;BUCCAL, SUBLINGUALEQ 0.6MG BASE0FENTANYL CITRATEFENTANYL CITRATE
006TABLET;BUCCAL, SUBLINGUALEQ 0.8MG BASE0FENTANYL CITRATEFENTANYL CITRATE

FDA Submissions

UNKNOWN; ORIG1AP2022-08-22STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
004PrescriptionAB
005PrescriptionAB
006PrescriptionAB

CDER Filings

MAYNE PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206329
            [companyName] => MAYNE PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"FENTANYL CITRATE","activeIngredients":"FENTANYL CITRATE","strength":"EQ 0.1MG BASE","dosageForm":"TABLET;BUCCAL, SUBLINGUAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FENTANYL CITRATE","activeIngredients":"FENTANYL CITRATE","strength":"EQ 0.2MG BASE","dosageForm":"TABLET;BUCCAL, SUBLINGUAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FENTANYL CITRATE","activeIngredients":"FENTANYL CITRATE","strength":"EQ 0.3MG BASE","dosageForm":"TABLET;BUCCAL, SUBLINGUAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"FENTANYL CITRATE","activeIngredients":"FENTANYL CITRATE","strength":"EQ 0.4MG BASE","dosageForm":"TABLET;BUCCAL, SUBLINGUAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FENTANYL CITRATE","activeIngredients":"FENTANYL CITRATE","strength":"EQ 0.6MG BASE","dosageForm":"TABLET;BUCCAL, SUBLINGUAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FENTANYL CITRATE","activeIngredients":"FENTANYL CITRATE","strength":"EQ 0.8MG BASE","dosageForm":"TABLET;BUCCAL, SUBLINGUAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/22\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-22
        )

)

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