Application Sponsors
| ANDA 213614 | MANKIND PHARMA | |
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 | 2020-09-09 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2022-05-26 | STANDARD |
| REMS; REMS | SUPPL | 10 | AP | 2021-10-18 | |
| REMS; REMS | SUPPL | 13 | AP | 2022-05-05 | |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 10 | Null | 7 |
| SUPPL | 13 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
MANKIND PHARMA
cder:Array
(
[0] => Array
(
[ApplNo] => 213614
[companyName] => MANKIND PHARMA
[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":"09\/09\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2020-09-09
)
)