Application Sponsors
Marketing Status
Application Products
001 | CAPSULE;ORAL | 10MG | 0 | DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2022-12-27 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
TWI PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 217054
[companyName] => TWI PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"DICYCLOMINE HYDROCHLORIDE","activeIngredients":"DICYCLOMINE HYDROCHLORIDE","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"12\/27\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2022-12-27
)
)