Application Sponsors
ANDA 075526 | SUN PHARM INDS INC | |
Marketing Status
Application Products
001 | TABLET;ORAL | 250MG | 0 | TICLOPIDINE HYDROCHLORIDE | TICLOPIDINE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 2002-09-26 | |
LABELING; Labeling | SUPPL | 2 | AP | 2003-01-31 | |
LABELING; Labeling | SUPPL | 11 | AP | 2015-09-11 | STANDARD |
Submissions Property Types
CDER Filings
SUN PHARM INDS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 75526
[companyName] => SUN PHARM INDS INC
[docInserts] => ["",""]
[products] => [{"drugName":"TICLOPIDINE HYDROCHLORIDE","activeIngredients":"TICLOPIDINE HYDROCHLORIDE","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"TICLOPIDINE HYDROCHLORIDE","submission":"TICLOPIDINE HYDROCHLORIDE","actionType":"250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)