ANDA 075384

MYLAN TECHNOLOGIES

FDA Drug Application

Application #075384

Documents

• Letter: 2000-12-01

Application Sponsors

ANDA 075384

MYLAN TECHNOLOGIES

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004

Application Products

001	CAPSULE;ORAL	EQ 1MG BASE	0	TERAZOSIN HYDROCHLORIDE	TERAZOSIN HYDROCHLORIDE
002	CAPSULE;ORAL	EQ 2MG BASE	0	TERAZOSIN HYDROCHLORIDE	TERAZOSIN HYDROCHLORIDE
003	CAPSULE;ORAL	EQ 5MG BASE	0	TERAZOSIN HYDROCHLORIDE	TERAZOSIN HYDROCHLORIDE
004	CAPSULE;ORAL	EQ 10MG BASE	0	TERAZOSIN HYDROCHLORIDE	TERAZOSIN HYDROCHLORIDE

FDA Submissions

ORIG

1

AP

2000-12-01

CDER Filings

MYLAN TECHNOLOGIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75384
            [companyName] => MYLAN TECHNOLOGIES
            [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
        )

)