Application Sponsors
| ANDA 078581 | SUN PHARM INDUSTRIES | |
Marketing Status
Application Products
| 001 | CAPSULE;ORAL | 7.5MG | 0 | TEMAZEPAM | TEMAZEPAM |
FDA Submissions
| ORIG | 1 | AP | 2009-09-08 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2011-02-04 | |
| LABELING; Labeling | SUPPL | 7 | AP | 2019-08-12 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2019-08-12 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2021-05-26 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 7 | Null | 15 |
| SUPPL | 8 | Null | 15 |
| SUPPL | 10 | Null | 15 |
TE Codes
CDER Filings
SUN PHARM INDUSTRIES
cder:Array
(
[0] => Array
(
[ApplNo] => 78581
[companyName] => SUN PHARM INDUSTRIES
[docInserts] => ["",""]
[products] => [{"drugName":"TEMAZEPAM","activeIngredients":"TEMAZEPAM","strength":"7.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"TEMAZEPAM","submission":"TEMAZEPAM","actionType":"7.5MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)