ANDA 203158

NORTEC DEV ASSOC

FDA Drug Application

Application #203158

Application Sponsors

ANDA 203158

NORTEC DEV ASSOC

Marketing Status

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

Application Products

001	CAPSULE, EXTENDED RELEASE;ORAL	20MG	0	MORPHINE SULFATE	MORPHINE SULFATE
002	CAPSULE, EXTENDED RELEASE;ORAL	30MG	0	MORPHINE SULFATE	MORPHINE SULFATE
003	CAPSULE, EXTENDED RELEASE;ORAL	50MG	0	MORPHINE SULFATE	MORPHINE SULFATE
004	CAPSULE, EXTENDED RELEASE;ORAL	60MG	0	MORPHINE SULFATE	MORPHINE SULFATE
005	CAPSULE, EXTENDED RELEASE;ORAL	80MG	0	MORPHINE SULFATE	MORPHINE SULFATE
006	CAPSULE, EXTENDED RELEASE;ORAL	100MG	0	MORPHINE SULFATE	MORPHINE SULFATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-08-04

Submissions Property Types

ORIG

1

Null

7

TE Codes

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

CDER Filings

NORTEC DEV ASSOC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203158
            [companyName] => NORTEC DEV ASSOC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"20MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"30MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"50MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"60MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"80MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"100MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/04\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-08-04
        )

)