Documents
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
| N/A; Not Applicable | ORIG | 1 | AP | 2015-05-04 | |
| REMS; REMS | SUPPL | 2 | AP | 2016-01-07 | |
| REMS; REMS | SUPPL | 3 | AP | 2016-03-24 | |
| REMS; REMS | SUPPL | 4 | AP | 2016-11-22 | |
| LABELING; Labeling | SUPPL | 5 | AP | 2019-12-06 | STANDARD |
| REMS; REMS | SUPPL | 7 | AP | 2021-10-18 | |
| REMS; REMS | SUPPL | 8 | AP | 2022-05-05 | |
Submissions Property Types
| ORIG | 1 | Null | 1 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 7 | Null | 15 |
| SUPPL | 8 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
HIKMA
cder:Array
(
[0] => Array
(
[ApplNo] => 200652
[companyName] => HIKMA
[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] => [{"actionDate":"05\/04\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/200652Orig1s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"05\/04\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/200652Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/200652Orig1s000ltr.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"12\/06\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/22\/2016","submission":"SUPPL-4","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/200652Orig1s004ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/200652Orig1s004.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"03\/24\/2016","submission":"SUPPL-3","supplementCategories":"REMS-Modified","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/07\/2016","submission":"SUPPL-2","supplementCategories":"REMS-Modified","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-12-06
)
)