Documents
Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | TABLET, EXTENDED RELEASE;ORAL | 100MG | 0 | MORPHINE SULFATE | MORPHINE SULFATE |
002 | TABLET, EXTENDED RELEASE;ORAL | 200MG | 0 | MORPHINE SULFATE | MORPHINE SULFATE |
FDA Submissions
| ORIG | 1 | AP | 1998-07-02 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2000-07-11 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2000-07-11 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2000-07-11 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2000-07-11 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2000-07-11 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2000-07-11 | |
REMS; REMS | SUPPL | 10 | AP | 2012-07-09 | |
LABELING; Labeling | SUPPL | 12 | AP | 2012-09-28 | |
REMS; REMS | SUPPL | 13 | AP | 2013-04-15 | |
LABELING; Labeling | SUPPL | 19 | AP | 2014-07-21 | STANDARD |
REMS; REMS | SUPPL | 20 | AP | 2014-08-19 | |
REMS; REMS | SUPPL | 22 | AP | 2015-06-26 | |
REMS; REMS | SUPPL | 24 | AP | 2016-04-20 | |
REMS; REMS | SUPPL | 27 | AP | 2016-09-30 | |
REMS; REMS | SUPPL | 28 | AP | 2017-05-26 | |
REMS; REMS | SUPPL | 29 | AP | 2018-09-18 | |
Submissions Property Types
SUPPL | 2 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 4 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 6 | Null | 0 |
SUPPL | 7 | Null | 0 |
SUPPL | 10 | Null | 7 |
SUPPL | 12 | Null | 15 |
SUPPL | 13 | Null | 15 |
SUPPL | 19 | Null | 7 |
SUPPL | 20 | Null | 7 |
SUPPL | 22 | Null | 15 |
SUPPL | 24 | Null | 15 |
SUPPL | 27 | Null | 7 |
SUPPL | 28 | Null | 15 |
SUPPL | 29 | Null | 15 |
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
CDER Filings
RHODES PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 74769
[companyName] => RHODES PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"100MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"200MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"07\/02\/1998","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/anda\\\/98\\\/74769ap_appltr_prntlbl_chemr.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"MORPHINE SULFATE","submission":"MORPHINE SULFATE","actionType":"100MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"MORPHINE SULFATE","submission":"MORPHINE SULFATE","actionType":"200MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1998-07-02
)
)