ANDA 211149

TEVA PHARMS USA

FDA Drug Application

Application #211149

Documents

• Letter: 2021-08-16

Application Sponsors

ANDA 211149

TEVA PHARMS USA

Marketing Status

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

Application Products

001	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	39MG/0.25ML (39MG/0.25ML)	0	PALIPERIDONE PALMITATE	PALIPERIDONE PALMITATE
002	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	78MG/0.5ML (78MG/0.5ML)	0	PALIPERIDONE PALMITATE	PALIPERIDONE PALMITATE
003	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	117MG/0.75ML (117MG/0.75ML)	0	PALIPERIDONE PALMITATE	PALIPERIDONE PALMITATE
004	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	156MG/ML (156MG/ML)	0	PALIPERIDONE PALMITATE	PALIPERIDONE PALMITATE
005	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	234MG/1.5ML (156MG/ML)	0	PALIPERIDONE PALMITATE	PALIPERIDONE PALMITATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-07-06

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP
004	Prescription	AP
005	Prescription	AP

CDER Filings

TEVA PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211149
            [companyName] => TEVA PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"PALIPERIDONE PALMITATE","activeIngredients":"PALIPERIDONE PALMITATE","strength":"39MG\/0.25ML (39MG\/0.25ML)","dosageForm":"SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PALIPERIDONE PALMITATE","activeIngredients":"PALIPERIDONE PALMITATE","strength":"78MG\/0.5ML (78MG\/0.5ML)","dosageForm":"SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PALIPERIDONE PALMITATE","activeIngredients":"PALIPERIDONE PALMITATE","strength":"117MG\/0.75ML (117MG\/0.75ML)","dosageForm":"SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PALIPERIDONE PALMITATE","activeIngredients":"PALIPERIDONE PALMITATE","strength":"156MG\/ML (156MG\/ML)","dosageForm":"SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PALIPERIDONE PALMITATE","activeIngredients":"PALIPERIDONE PALMITATE","strength":"234MG\/1.5ML (156MG\/ML)","dosageForm":"SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/06\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-07-06
        )

)