Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | CAPSULE, EXTENDED RELEASE;ORAL | 120MG | 0 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE |
002 | CAPSULE, EXTENDED RELEASE;ORAL | 180MG | 0 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE |
003 | CAPSULE, EXTENDED RELEASE;ORAL | 240MG | 0 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2022-08-08 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB2 |
002 | Prescription | AB2 |
003 | Prescription | AB2 |
CDER Filings
AMTA
cder:Array
(
[0] => Array
(
[ApplNo] => 216304
[companyName] => AMTA
[docInserts] => ["",""]
[products] => [{"drugName":"DILTIAZEM HYDROCHLORIDE","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"120MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DILTIAZEM HYDROCHLORIDE","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"180MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DILTIAZEM HYDROCHLORIDE","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"240MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"08\/08\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2022-08-08
)
)