Application Sponsors
| ANDA 078225 | ZYDUS PHARMS USA INC | |
Marketing Status
Application Products
| 001 | CAPSULE;ORAL | 0.4MG | 0 | TAMSULOSIN HYDROCHLORIDE | TAMSULOSIN HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 2010-04-27 | |
| LABELING; Labeling | SUPPL | 4 | AP | 2011-08-29 | |
| LABELING; Labeling | SUPPL | 5 | AP | 2015-04-22 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2015-04-22 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2019-09-09 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 14 | Null | 7 |
TE Codes
CDER Filings
ZYDUS PHARMS USA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 78225
[companyName] => ZYDUS PHARMS USA INC
[docInserts] => ["",""]
[products] => [{"drugName":"TAMSULOSIN HYDROCHLORIDE","activeIngredients":"TAMSULOSIN HYDROCHLORIDE","strength":"0.4MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"TAMSULOSIN HYDROCHLORIDE","submission":"TAMSULOSIN HYDROCHLORIDE","actionType":"0.4MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)