Application Sponsors
| ANDA 090529 | SUN PHARM INDS INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | TABLET, EXTENDED RELEASE;ORAL | 120MG | 0 | VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE |
| 002 | TABLET, EXTENDED RELEASE;ORAL | 180MG | 0 | VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE |
| 003 | TABLET, EXTENDED RELEASE;ORAL | 240MG | 0 | VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 2011-12-30 | |
| LABELING; Labeling | SUPPL | 11 | AP | 2019-09-24 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2019-09-24 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 11 | Null | 7 |
| SUPPL | 13 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
SUN PHARM INDS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 90529
[companyName] => SUN PHARM INDS INC
[docInserts] => ["",""]
[products] => [{"drugName":"VERAPAMIL HYDROCHLORIDE","activeIngredients":"VERAPAMIL HYDROCHLORIDE","strength":"120MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VERAPAMIL HYDROCHLORIDE","activeIngredients":"VERAPAMIL HYDROCHLORIDE","strength":"180MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VERAPAMIL HYDROCHLORIDE","activeIngredients":"VERAPAMIL HYDROCHLORIDE","strength":"240MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"VERAPAMIL HYDROCHLORIDE","submission":"VERAPAMIL HYDROCHLORIDE","actionType":"120MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"VERAPAMIL HYDROCHLORIDE","submission":"VERAPAMIL HYDROCHLORIDE","actionType":"180MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"VERAPAMIL HYDROCHLORIDE","submission":"VERAPAMIL HYDROCHLORIDE","actionType":"240MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)