Application Sponsors
ANDA 216379 | EUGIA PHARMA SPECLTS | |
Marketing Status
None (Tentative Approval) | 001 |
None (Tentative Approval) | 002 |
Application Products
002 | SOLUTION;INTRAVENOUS | EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) | 0 | TIROFIBAN HYDROCHLORIDE | TIROFIBAN HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2022-04-21 | STANDARD |
Submissions Property Types
CDER Filings
EUGIA PHARMA SPECLTS
cder:Array
(
[0] => Array
(
[ApplNo] => 216379
[companyName] => EUGIA PHARMA SPECLTS
[docInserts] => ["",""]
[products] => [{"drugName":"TIROFIBAN HYDROCHLORIDE","activeIngredients":"TIROFIBAN HYDROCHLORIDE","strength":"EQ 5MG BASE\/100ML (EQ 0.05MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"TIROFIBAN HYDROCHLORIDE","activeIngredients":"TIROFIBAN HYDROCHLORIDE","strength":"EQ 12.5MG BASE\/250ML (EQ 0.05MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"04\/21\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2022-04-21
)
)