Application Sponsors
Marketing Status
Application Products
001 | SYRUP;ORAL | 2MG/5ML;10MG/5ML;30MG/5ML | 0 | BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2020-09-30 | |
Submissions Property Types
TE Codes
CDER Filings
BRECKENRIDGE
cder:Array
(
[0] => Array
(
[ApplNo] => 203997
[companyName] => BRECKENRIDGE
[docInserts] => ["",""]
[products] => [{"drugName":"BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE","activeIngredients":"BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE","strength":"2MG\/5ML;10MG\/5ML;30MG\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"09\/30\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2020-09-30
)
)