Application Sponsors
ANDA 200770 | STRIDES PHARMA | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Discontinued | 004 |
Application Products
001 | TABLET;ORAL | 25MG | 0 | HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE |
002 | TABLET;ORAL | 50MG | 0 | HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE |
003 | TABLET;ORAL | 100MG | 0 | HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE |
004 | TABLET;ORAL | 10MG | 0 | HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE |
FDA Submissions
N/A; Not Applicable | ORIG | 1 | AP | 2013-05-03 | |
Submissions Property Types
TE Codes
001 | Prescription | AA |
002 | Prescription | AA |
003 | Prescription | AA |
CDER Filings
STRIDES PHARMA
cder:Array
(
[0] => Array
(
[ApplNo] => 200770
[companyName] => STRIDES PHARMA
[docInserts] => ["",""]
[products] => [{"drugName":"HYDRALAZINE HYDROCHLORIDE","activeIngredients":"HYDRALAZINE HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HYDRALAZINE HYDROCHLORIDE","activeIngredients":"HYDRALAZINE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HYDRALAZINE HYDROCHLORIDE","activeIngredients":"HYDRALAZINE HYDROCHLORIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HYDRALAZINE HYDROCHLORIDE","activeIngredients":"HYDRALAZINE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"05\/03\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2013-05-03
)
)