Application Sponsors
ANDA 210788 | CUSTOPHARM INC | |
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | 10MG/ML | 0 | DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2019-02-11 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
CUSTOPHARM INC
cder:Array
(
[0] => Array
(
[ApplNo] => 210788
[companyName] => CUSTOPHARM INC
[docInserts] => ["",""]
[products] => [{"drugName":"DICYCLOMINE HYDROCHLORIDE","activeIngredients":"DICYCLOMINE HYDROCHLORIDE","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"02\/11\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2019-02-11
)
)