ANDA 202104

UPSHER SMITH LABS

FDA Drug Application

Application #202104

Documents

• Other: 2015-06-30

Application Sponsors

ANDA 202104

UPSHER SMITH LABS

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 006
• Prescription: 007

Application Products

001	CAPSULE, EXTENDED RELEASE;ORAL	10MG	0	MORPHINE SULFATE	MORPHINE SULFATE
002	CAPSULE, EXTENDED RELEASE;ORAL	20MG	0	MORPHINE SULFATE	MORPHINE SULFATE
003	CAPSULE, EXTENDED RELEASE;ORAL	30MG	0	MORPHINE SULFATE	MORPHINE SULFATE
004	CAPSULE, EXTENDED RELEASE;ORAL	50MG	0	MORPHINE SULFATE	MORPHINE SULFATE
005	CAPSULE, EXTENDED RELEASE;ORAL	60MG	0	MORPHINE SULFATE	MORPHINE SULFATE
006	CAPSULE, EXTENDED RELEASE;ORAL	80MG	0	MORPHINE SULFATE	MORPHINE SULFATE
007	CAPSULE, EXTENDED RELEASE;ORAL	100MG	0	MORPHINE SULFATE	MORPHINE SULFATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2013-06-03
LABELING; Labeling	SUPPL	2	AP	2014-07-15	STANDARD
REMS; REMS	SUPPL	4	AP	2014-08-19
REMS; REMS	SUPPL	5	AP	2015-06-26
REMS; REMS	SUPPL	6	AP	2016-04-20
REMS; REMS	SUPPL	7	AP	2016-09-30
REMS; REMS	SUPPL	9	AP	2017-05-26
REMS; REMS	SUPPL	11	AP	2018-09-18
LABELING; Labeling	SUPPL	13	AP	2021-12-15	STANDARD
LABELING; Labeling	SUPPL	14	AP	2021-12-15	STANDARD
LABELING; Labeling	SUPPL	18	AP	2021-12-15	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	4	Null	15
SUPPL	5	Null	7
SUPPL	6	Null	7
SUPPL	7	Null	7
SUPPL	9	Null	7
SUPPL	11	Null	7
SUPPL	13	Null	7
SUPPL	14	Null	7
SUPPL	18	Null	7

TE Codes

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

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202104
            [companyName] => UPSHER SMITH LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"10MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"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":"06\/03\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/18\/2018","submission":"SUPPL-11","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/26\/2017","submission":"SUPPL-9","supplementCategories":"REMS-Modified","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/30\/2016","submission":"SUPPL-7","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/20\/2016","submission":"SUPPL-6","supplementCategories":"REMS-Modified","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/26\/2015","submission":"SUPPL-5","supplementCategories":"REMS-Modified","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/19\/2014","submission":"SUPPL-4","supplementCategories":"REMS-Modified","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/15\/2014","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-09-18
        )

)