BEXIMCO PHARMS USA FDA Approval ANDA 075667

ANDA 075667

BEXIMCO PHARMS USA

FDA Drug Application

Application #075667

Documents

Letter2000-07-28

Application Sponsors

ANDA 075667BEXIMCO PHARMS USA

Marketing Status

Discontinued001
Discontinued002
Discontinued003
Discontinued004

Application Products

001CAPSULE;ORALEQ 1MG BASE0TERAZOSIN HYDROCHLORIDETERAZOSIN HYDROCHLORIDE
002CAPSULE;ORALEQ 2MG BASE0TERAZOSIN HYDROCHLORIDETERAZOSIN HYDROCHLORIDE
003CAPSULE;ORALEQ 5MG BASE0TERAZOSIN HYDROCHLORIDETERAZOSIN HYDROCHLORIDE
004CAPSULE;ORALEQ 10MG BASE0TERAZOSIN HYDROCHLORIDETERAZOSIN HYDROCHLORIDE

FDA Submissions

ORIG1AP2000-07-28

CDER Filings

BEXIMCO PHARMS USA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75667
            [companyName] => BEXIMCO PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"TERAZOSIN HYDROCHLORIDE","activeIngredients":"TERAZOSIN HYDROCHLORIDE","strength":"EQ 1MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TERAZOSIN HYDROCHLORIDE","activeIngredients":"TERAZOSIN HYDROCHLORIDE","strength":"EQ 2MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TERAZOSIN HYDROCHLORIDE","activeIngredients":"TERAZOSIN HYDROCHLORIDE","strength":"EQ 5MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TERAZOSIN HYDROCHLORIDE","activeIngredients":"TERAZOSIN HYDROCHLORIDE","strength":"EQ 10MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TERAZOSIN HYDROCHLORIDE","submission":"TERAZOSIN HYDROCHLORIDE","actionType":"EQ 1MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TERAZOSIN HYDROCHLORIDE","submission":"TERAZOSIN HYDROCHLORIDE","actionType":"EQ 2MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TERAZOSIN HYDROCHLORIDE","submission":"TERAZOSIN HYDROCHLORIDE","actionType":"EQ 5MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TERAZOSIN HYDROCHLORIDE","submission":"TERAZOSIN HYDROCHLORIDE","actionType":"EQ 10MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.