Application Sponsors
Marketing Status
Application Products
001 | SOLUTION;ORAL | 4MG/5ML;5MG/5ML;60MG/5ML | 0 | HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE | CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2017-05-15 | STANDARD |
Submissions Property Types
CDER Filings
TORRENT
cder:Array
(
[0] => Array
(
[ApplNo] => 206660
[companyName] => TORRENT
[docInserts] => ["",""]
[products] => [{"drugName":"HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE","activeIngredients":"CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE","strength":"4MG\/5ML;5MG\/5ML;60MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"05\/15\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2017-05-15
)
)