Application Sponsors
ANDA 211596 | EDENBRIDGE PHARMS | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Prescription | 004 |
Application Products
001 | TABLET;ORAL | 30MG | 0 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE |
002 | TABLET;ORAL | 60MG | 0 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE |
003 | TABLET;ORAL | 90MG | 0 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE |
004 | TABLET;ORAL | 120MG | 0 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2019-11-18 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
004 | Prescription | AB |
CDER Filings
EDENBRIDGE PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 211596
[companyName] => EDENBRIDGE PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"DILTIAZEM HYDROCHLORIDE","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DILTIAZEM HYDROCHLORIDE","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"60MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DILTIAZEM HYDROCHLORIDE","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"90MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DILTIAZEM HYDROCHLORIDE","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"120MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"11\/18\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2019-11-18
)
)