Application Sponsors
Marketing Status
Application Products
001 | TABLET;ORAL | 1.5MG;5MG | 0 | HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE | HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2017-08-07 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
AVANTHI INC
cder:Array
(
[0] => Array
(
[ApplNo] => 207176
[companyName] => AVANTHI INC
[docInserts] => ["",""]
[products] => [{"drugName":"HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE","activeIngredients":"HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE","strength":"1.5MG;5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"08\/07\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"07\/05\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2018-07-05
)
)