Documents
Application Sponsors
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | EQ 2MG BASE/ML | 0 | ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2014-09-08 | |
LABELING; Labeling | SUPPL | 2 | AP | 2021-09-01 | STANDARD |
LABELING; Labeling | SUPPL | 10 | AP | 2021-09-01 | STANDARD |
LABELING; Labeling | SUPPL | 13 | AP | 2022-02-28 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 1 |
SUPPL | 2 | Null | 7 |
SUPPL | 10 | Null | 7 |
SUPPL | 13 | Null | 15 |
TE Codes
CDER Filings
QILU
cder:Array
(
[0] => Array
(
[ApplNo] => 203711
[companyName] => QILU
[docInserts] => ["",""]
[products] => [{"drugName":"ONDANSETRON HYDROCHLORIDE","activeIngredients":"ONDANSETRON HYDROCHLORIDE","strength":"EQ 2MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
[labels] => [{"actionDate":"09\/08\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/203711Orig1s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"09\/08\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/203711Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/203711Orig1s000ltr.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"04\/03\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2015-04-03
)
)