Documents
Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | SPRAY, METERED;NASAL | 0.1% | 0 | ASTEPRO | AZELASTINE HYDROCHRLORIDE |
002 | SPRAY, METERED;NASAL | 0.15% | 0 | ASTEPRO | AZELASTINE HYDROCHRLORIDE |
FDA Submissions
TYPE 6; Type 6 - New Indication (no longer used) | ORIG | 1 | AP | 2009-08-31 | STANDARD |
Submissions Property Types
CDER Filings
MEDA PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 22371
[companyName] => MEDA PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"ASTEPRO","activeIngredients":"AZELASTINE HYDROCHRLORIDE","strength":"0.1%","dosageForm":"SPRAY, METERED;NASAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"ASTEPRO","activeIngredients":"AZELASTINE HYDROCHRLORIDE","strength":"0.15%","dosageForm":"SPRAY, METERED;NASAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ASTEPRO","submission":"AZELASTINE HYDROCHRLORIDE","actionType":"0.1%","submissionClassification":"SPRAY, METERED;NASAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ASTEPRO","submission":"AZELASTINE HYDROCHRLORIDE","actionType":"0.15%","submissionClassification":"SPRAY, METERED;NASAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)