Application Sponsors
Marketing Status
Application Products
001 | SYRUP;ORAL | EQ 15MG BASE/ML | 0 | RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 2009-05-26 | |
LABELING; Labeling | SUPPL | 2 | AP | 2010-04-30 | |
CDER Filings
TORRENT
cder:Array
(
[0] => Array
(
[ApplNo] => 90102
[companyName] => TORRENT
[docInserts] => ["",""]
[products] => [{"drugName":"RANITIDINE HYDROCHLORIDE","activeIngredients":"RANITIDINE HYDROCHLORIDE","strength":"EQ 15MG BASE\/ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"RANITIDINE HYDROCHLORIDE","submission":"RANITIDINE HYDROCHLORIDE","actionType":"EQ 15MG BASE\/ML","submissionClassification":"SYRUP;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)