Application Sponsors
| ANDA 214219 | RICONPHARMA LLC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 0.125MG | 0 | TRIAZOLAM | TRIAZOLAM |
| 002 | TABLET;ORAL | 0.25MG | 0 | TRIAZOLAM | TRIAZOLAM |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2020-10-20 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2022-07-26 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2022-07-26 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 4 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
RICONPHARMA LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 214219
[companyName] => RICONPHARMA LLC
[docInserts] => ["",""]
[products] => [{"drugName":"TRIAZOLAM","activeIngredients":"TRIAZOLAM","strength":"0.125MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TRIAZOLAM","activeIngredients":"TRIAZOLAM","strength":"0.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"10\/20\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"10\/22\/2020","submission":"SUPPL-1","supplementCategories":"","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-10-22
)
)