Documents
Application Sponsors
| NDA 205596 | MERCK SHARP DOHME | |
Marketing Status
Application Products
| 001 | SOLUTION;INTRAVENOUS | 300MG/16.7ML (18MG/ML) | 1 | NOXAFIL | POSACONAZOLE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2014-03-13 | PRIORITY |
| LABELING; Labeling | SUPPL | 3 | AP | 2015-11-13 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2016-09-09 | STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
| LABELING; Labeling | SUPPL | 5 | AP | 2018-01-04 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2019-03-11 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2019-02-21 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2020-09-16 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 12 | AP | 2021-05-31 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 13 | AP | 2021-06-17 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2022-01-20 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2022-01-13 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 7 | Null | 31 |
| SUPPL | 8 | Null | 15 |
| SUPPL | 10 | Null | 15 |
| SUPPL | 12 | Null | 7 |
| SUPPL | 13 | Null | 15 |
| SUPPL | 14 | Null | 15 |
| SUPPL | 15 | Null | 6 |
TE Codes
CDER Filings
MERCK SHARP DOHME
cder:Array
(
[0] => Array
(
[ApplNo] => 205596
[companyName] => MERCK SHARP DOHME
[docInserts] => ["",""]
[products] => [{"drugName":"NOXAFIL","activeIngredients":"POSACONAZOLE","strength":"300MG\/16.7ML (18MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"09\/16\/2020","submission":"SUPPL-10","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022003s026,205053s010,205596s010lbl.pdf\"}]","notes":""},{"actionDate":"09\/16\/2020","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022003s026,205053s010,205596s010lbl.pdf\"}]","notes":""},{"actionDate":"03\/11\/2019","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022003s024,205053s008,205596s007lbl.pdf\"}]","notes":""},{"actionDate":"02\/21\/2019","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022003s025,205053s009,205596s008lbl.pdf\"}]","notes":""},{"actionDate":"01\/04\/2018","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022003s022,205053s006,205596s005lbl.pdf\"}]","notes":""},{"actionDate":"09\/09\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022003s021,205053s005,205596s004lbl.pdf\"}]","notes":"Please see"},{"actionDate":"11\/13\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022003s018s020,0205053s002s004,0205596s001s003lbl.pdf\"}]","notes":""},{"actionDate":"11\/13\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022003s018s020,0205053s002s004,0205596s001s003lbl.pdf\"}]","notes":""},{"actionDate":"11\/13\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022003s018s020,0205053s002s004,0205596s001s003lbl.pdf\"}]","notes":""},{"actionDate":"11\/13\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022003s018s020,0205053s002s004,0205596s001s003lbl.pdf\"}]","notes":""},{"actionDate":"03\/13\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/205596s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"03\/13\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/205596s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/205596Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/205596Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/205596Orig1s000SumR.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"09\/16\/2020","submission":"SUPPL-10","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022003s026,205053s010,205596s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/022003Orig1s026,205053Orig1s010,205596Orig1s010ltr.pdf\"}]","notes":">"},{"actionDate":"02\/21\/2019","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022003s025,205053s009,205596s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/022003Orig1s025,205053Orig1s009,205596Orig1s008ltr.pdf\"}]","notes":">"},{"actionDate":"03\/11\/2019","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022003s024,205053s008,205596s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"01\/04\/2018","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022003s022,205053s006,205596s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/022003Orig1s022,205053Orig1s006,205596Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"09\/09\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022003s021,205053s005,205596s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/022003Orig1s021,205053Orig1s005,205596Orig1s004ltr.pdf\"}]","notes":"> Please see www.fda.gov\/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs."},{"actionDate":"11\/13\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022003s018s020,0205053s002s004,0205596s001s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/022003Orig1s018,s020,205053Orig1s002,s004,205596Orig1s001,s003ltr.pdf\"}]","notes":">"},{"actionDate":"11\/13\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022003s018s020,0205053s002s004,0205596s001s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/022003Orig1s018,s020,205053Orig1s002,s004,205596Orig1s001,s003ltr.pdf\"}]","notes":">"}]
[actionDate] => 2020-09-16
)
)