Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Prescription | 004 |
Prescription | 005 |
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 |
004 | CAPSULE, EXTENDED RELEASE;ORAL | 300MG | 0 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE |
005 | CAPSULE, EXTENDED RELEASE;ORAL | 360MG | 0 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2018-08-30 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB3 |
002 | Prescription | AB3 |
003 | Prescription | AB3 |
004 | Prescription | AB3 |
005 | Prescription | AB3 |
CDER Filings
TWI PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 205231
[companyName] => TWI PHARMS
[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"},{"drugName":"DILTIAZEM HYDROCHLORIDE","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"300MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DILTIAZEM HYDROCHLORIDE","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"360MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"08\/30\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2018-08-30
)
)