Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
| Discontinued | 004 |
| Discontinued | 005 |
Application Products
| 001 | SOLUTION;INTRAVENOUS | EQ 2MG BASE/ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | MIVACRON | MIVACURIUM CHLORIDE |
| 002 | INJECTABLE;INJECTION | EQ 0.5MG BASE/ML | 0 | MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER | MIVACURIUM CHLORIDE |
| 003 | INJECTABLE;INJECTION | EQ 50MG BASE/100ML | 0 | MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER | MIVACURIUM CHLORIDE |
| 004 | SOLUTION;INTRAVENOUS | EQ 10MG BASE/5ML (EQ 2MG BASE/ML) | 1 | MIVACRON | MIVACURIUM CHLORIDE |
| 005 | SOLUTION;INTRAVENOUS | EQ 20MG BASE/10ML (EQ 2MG BASE/ML) | 1 | MIVACRON | MIVACURIUM CHLORIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1992-01-22 | PRIORITY |
| LABELING; Labeling | SUPPL | 2 | AP | 1994-03-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1994-04-15 | PRIORITY |
| LABELING; Labeling | SUPPL | 4 | AP | 1994-01-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1994-08-18 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1995-06-09 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1997-06-04 | PRIORITY |
| LABELING; Labeling | SUPPL | 9 | AP | 1998-05-19 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 1999-06-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1999-03-17 | PRIORITY |
| LABELING; Labeling | SUPPL | 12 | AP | 2001-02-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2002-06-04 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2002-10-15 | PRIORITY |
| LABELING; Labeling | SUPPL | 17 | AP | 2010-11-22 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2015-01-30 | PRIORITY |
| LABELING; Labeling | SUPPL | 19 | AP | 2018-07-26 | STANDARD |
Submissions Property Types
| SUPPL | 3 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 17 | Null | 7 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 6 |
CDER Filings
ABBVIE
cder:Array
(
[0] => Array
(
[ApplNo] => 20098
[companyName] => ABBVIE
[docInserts] => ["",""]
[products] => [{"drugName":"MIVACRON","activeIngredients":"MIVACURIUM CHLORIDE","strength":"EQ 2MG BASE\/ML (EQ 2MG BASE\/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"MIVACRON","activeIngredients":"MIVACURIUM CHLORIDE","strength":"EQ 10MG BASE\/5ML (EQ 2MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"MIVACRON","activeIngredients":"MIVACURIUM CHLORIDE","strength":"EQ 20MG BASE\/10ML (EQ 2MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"MIVACURIUM CHLORIDE","strength":"EQ 0.5MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"MIVACURIUM CHLORIDE","strength":"EQ 50MG BASE\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"07\/26\/2018","submission":"SUPPL-19","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020098s019lbl.pdf\"}]","notes":""},{"actionDate":"07\/26\/2018","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020098s019lbl.pdf\"}]","notes":""},{"actionDate":"01\/30\/2015","submission":"SUPPL-18","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020098s018lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"11\/22\/2010","submission":"SUPPL-17","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020098s017lbl.pdf\"}]","notes":""},{"actionDate":"05\/19\/1998","submission":"SUPPL-9","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/98\\\/20098S009_Mivacron_appltr_prntlbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"MIVACRON","submission":"MIVACURIUM CHLORIDE","actionType":"EQ 2MG BASE\/ML (EQ 2MG BASE\/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"SOLUTION;INTRAVENOUS","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"MIVACRON","submission":"MIVACURIUM CHLORIDE","actionType":"EQ 10MG BASE\/5ML (EQ 2MG BASE\/ML)","submissionClassification":"SOLUTION;INTRAVENOUS","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"MIVACRON","submission":"MIVACURIUM CHLORIDE","actionType":"EQ 20MG BASE\/10ML (EQ 2MG BASE\/ML)","submissionClassification":"SOLUTION;INTRAVENOUS","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"MIVACURIUM CHLORIDE","actionType":"EQ 0.5MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"MIVACURIUM CHLORIDE","actionType":"EQ 50MG BASE\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2018-07-26
)
)