Application Sponsors
ANDA 210228 | UNIQUE PHARM LABS | |
Marketing Status
Application Products
001 | TABLET;ORAL | EQ 150MG BASE | 0 | RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2019-08-30 | STANDARD |
Submissions Property Types
CDER Filings
UNIQUE PHARM LABS
cder:Array
(
[0] => Array
(
[ApplNo] => 210228
[companyName] => UNIQUE PHARM LABS
[docInserts] => ["",""]
[products] => [{"drugName":"RANITIDINE HYDROCHLORIDE","activeIngredients":"RANITIDINE HYDROCHLORIDE","strength":"EQ 150MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"08\/30\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2019-08-30
)
)