Documents
Application Sponsors
NDA 208943 | PAR STERILE PRODUCTS | |
Marketing Status
Application Products
001 | SOLUTION;INTRAVENOUS | 50MG/ML (50MG/ML) | 0 | CORPHEDRA | EPHEDRINE SULFATE |
FDA Submissions
TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2017-01-27 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
PAR STERILE PRODUCTS
cder:Array
(
[0] => Array
(
[ApplNo] => 208943
[companyName] => PAR STERILE PRODUCTS
[docInserts] => ["",""]
[products] => [{"drugName":"CORPHEDRA","activeIngredients":"EPHEDRINE SULFATE","strength":"50MG\/ML (50MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"01\/27\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208943s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"01\/27\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208943s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208943Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/208943Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2017-01-27
)
)