Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | N/A | 1 | MYOVIEW | TECHNETIUM TC-99M TETROFOSMIN KIT |
| 002 | INJECTABLE;INJECTION | N/A | 1 | MYOVIEW 30ML | TECHNETIUM TC-99M TETROFOSMIN KIT |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1996-02-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1998-12-09 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 3 | AP | 2001-11-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1999-11-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2000-04-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2000-04-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2000-09-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2001-04-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2001-08-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2001-12-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2002-05-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2002-11-25 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 13 | AP | 2003-02-28 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2003-11-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2005-07-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 2009-02-26 | N/A |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 2013-03-08 | STANDARD |
| LABELING; Labeling | SUPPL | 28 | AP | 2017-04-17 | STANDARD |
| LABELING; Labeling | SUPPL | 31 | AP | 2022-03-09 | STANDARD |
| LABELING; Labeling | SUPPL | 33 | TA | 2022-06-07 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 28 | Null | 7 |
| SUPPL | 31 | Null | 15 |
CDER Filings
GE HEALTHCARE
cder:Array
(
[0] => Array
(
[ApplNo] => 20372
[companyName] => GE HEALTHCARE
[docInserts] => ["",""]
[products] => [{"drugName":"MYOVIEW","activeIngredients":"TECHNETIUM TC-99M TETROFOSMIN KIT","strength":"N\/A","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"MYOVIEW 30ML","activeIngredients":"TECHNETIUM TC-99M TETROFOSMIN KIT","strength":"N\/A","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"04\/17\/2017","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020372s028lbl.pdf\"}]","notes":""},{"actionDate":"02\/26\/2009","submission":"SUPPL-22","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020372s022lbl.pdf\"}]","notes":""},{"actionDate":"02\/26\/2009","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020372s022lbl.pdf\"}]","notes":""},{"actionDate":"07\/07\/2005","submission":"SUPPL-19","supplementCategories":"Manufacturing (CMC)-Formulation","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020372s019lbl.pdf\"}]","notes":""},{"actionDate":"11\/13\/2003","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20372slr015_myoview_lbl.pdf\"}]","notes":""},{"actionDate":"02\/28\/2003","submission":"SUPPL-13","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/020372s013lbl.pdf\"}]","notes":""},{"actionDate":"11\/23\/2001","submission":"SUPPL-3","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2001\\\/20372_Myoview_prntlbl.pdf\"}]","notes":""},{"actionDate":"08\/27\/2001","submission":"SUPPL-9","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/20372s9lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."}]
[originalApprovals] => [{"actionDate":"MYOVIEW","submission":"TECHNETIUM TC-99M TETROFOSMIN KIT","actionType":"N\/A","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"MYOVIEW 30ML","submission":"TECHNETIUM TC-99M TETROFOSMIN KIT","actionType":"N\/A","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2017-04-17
)
)