Application Sponsors
ANDA 202710 | STRIDES PHARMA | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | TABLET;ORAL | 250MG | 0 | CLARITHROMYCIN | CLARITHROMYCIN |
002 | TABLET;ORAL | 500MG | 0 | CLARITHROMYCIN | CLARITHROMYCIN |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2013-06-10 | |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
CDER Filings
STRIDES PHARMA
cder:Array
(
[0] => Array
(
[ApplNo] => 202710
[companyName] => STRIDES PHARMA
[docInserts] => ["",""]
[products] => [{"drugName":"CLARITHROMYCIN","activeIngredients":"CLARITHROMYCIN","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CLARITHROMYCIN","activeIngredients":"CLARITHROMYCIN","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"06\/10\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"08\/28\/2014","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2014-08-28
)
)