ANDA 206329

MAYNE PHARMA

FDA Drug Application

Application #206329

Application Sponsors

ANDA 206329

MAYNE PHARMA

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 006

Application Products

001	TABLET;BUCCAL, SUBLINGUAL	EQ 0.1MG BASE	0	FENTANYL CITRATE	FENTANYL CITRATE
002	TABLET;BUCCAL, SUBLINGUAL	EQ 0.2MG BASE	0	FENTANYL CITRATE	FENTANYL CITRATE
003	TABLET;BUCCAL, SUBLINGUAL	EQ 0.3MG BASE	0	FENTANYL CITRATE	FENTANYL CITRATE
004	TABLET;BUCCAL, SUBLINGUAL	EQ 0.4MG BASE	0	FENTANYL CITRATE	FENTANYL CITRATE
005	TABLET;BUCCAL, SUBLINGUAL	EQ 0.6MG BASE	0	FENTANYL CITRATE	FENTANYL CITRATE
006	TABLET;BUCCAL, SUBLINGUAL	EQ 0.8MG BASE	0	FENTANYL CITRATE	FENTANYL CITRATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-08-22

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB
004	Prescription	AB
005	Prescription	AB
006	Prescription	AB

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
        )

)