Application Sponsors
ANDA 216521 | SCIEGEN PHARMS INC | |
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 | 2022-09-23 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
004 | Prescription | AB |
CDER Filings
SCIEGEN PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 216521
[companyName] => SCIEGEN PHARMS INC
[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":"DILTIAZEM HYDROCHLORIDE","submission":"DILTIAZEM HYDROCHLORIDE","actionType":"30MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DILTIAZEM HYDROCHLORIDE","submission":"DILTIAZEM HYDROCHLORIDE","actionType":"60MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DILTIAZEM HYDROCHLORIDE","submission":"DILTIAZEM HYDROCHLORIDE","actionType":"90MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DILTIAZEM HYDROCHLORIDE","submission":"DILTIAZEM HYDROCHLORIDE","actionType":"120MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)