Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Discontinued | 002 |
Application Products
| 001 | SPRAY, METERED;NASAL | 4MG/SPRAY | 1 | NARCAN | NALOXONE HYDROCHLORIDE |
| 002 | SPRAY, METERED;NASAL | 2MG/SPRAY | 1 | NARCAN | NALOXONE HYDROCHLORIDE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2015-11-18 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2019-09-23 | N/A |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2020-08-06 | N/A |
Submissions Property Types
TE Codes
CDER Filings
EMERGENT
cder:Array
(
[0] => Array
(
[ApplNo] => 208411
[companyName] => EMERGENT
[docInserts] => ["",""]
[products] => [{"drugName":"NARCAN","activeIngredients":"NALOXONE HYDROCHLORIDE","strength":"4MG\/SPRAY","dosageForm":"SPRAY, METERED;NASAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"NARCAN","activeIngredients":"NALOXONE HYDROCHLORIDE","strength":"2MG\/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"SPRAY, METERED;NASAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"08\/06\/2020","submission":"SUPPL-4","supplementCategories":"Manufacturing (CMC)-Expiration Date","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208411Orig1s004lbl.pdf\"}]","notes":""},{"actionDate":"09\/23\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208411Orig1s002lbl.pdf\"}]","notes":""},{"actionDate":"01\/24\/2017","submission":"SUPPL-1","supplementCategories":"Efficacy-Manufacturing Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208411s001lbl.pdf\"}]","notes":""},{"actionDate":"11\/18\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/208411lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"11\/18\/2015","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\\\/2015\\\/208411lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/208411Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/208411Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"08\/06\/2020","submission":"SUPPL-4","supplementCategories":"Manufacturing (CMC)-Expiration Date","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208411Orig1s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/208411Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"09\/23\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208411Orig1s002lbl.pdf\"}]","notes":">"},{"actionDate":"01\/24\/2017","submission":"SUPPL-1","supplementCategories":"Efficacy-Manufacturing Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208411s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208411Orig1s001ltr.pdf\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/summary_review\\\/2017\\\/208411s001SumR.pdf\"}]","notes":">"}]
[actionDate] => 2020-08-06
)
)