Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | EQ 0.5MG BASE | 0 | ALOSETRON HYDROCHLORIDE | ALOSETRON HYDROCHLORIDE |
| 002 | TABLET;ORAL | EQ 1MG BASE | 0 | ALOSETRON HYDROCHLORIDE | ALOSETRON HYDROCHLORIDE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2018-02-23 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2019-12-06 | STANDARD |
| REMS; REMS | SUPPL | 4 | AP | 2021-10-18 | |
| REMS; REMS | SUPPL | 5 | AP | 2022-05-05 | |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 5 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
PAR PHARM INC
cder:Array
(
[0] => Array
(
[ApplNo] => 206113
[companyName] => PAR PHARM INC
[docInserts] => ["",""]
[products] => [{"drugName":"ALOSETRON HYDROCHLORIDE","activeIngredients":"ALOSETRON HYDROCHLORIDE","strength":"EQ 0.5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ALOSETRON HYDROCHLORIDE","activeIngredients":"ALOSETRON HYDROCHLORIDE","strength":"EQ 1MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"02\/23\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"12\/06\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-12-06
)
)