ANDA 075317

JUBILANT CADISTA

FDA Drug Application

Application #075317

Application Sponsors

ANDA 075317

JUBILANT CADISTA

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 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	2004-12-20
LABELING; Labeling	SUPPL	4	AP	2007-05-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2015-03-20	UNKNOWN

Submissions Property Types

SUPPL

11

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

JUBILANT CADISTA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75317
            [companyName] => JUBILANT CADISTA
            [docInserts] => ["",""]
            [products] => [{"drugName":"TERAZOSIN HYDROCHLORIDE","activeIngredients":"TERAZOSIN HYDROCHLORIDE","strength":"EQ 1MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"},{"drugName":"TERAZOSIN HYDROCHLORIDE","activeIngredients":"TERAZOSIN HYDROCHLORIDE","strength":"EQ 2MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TERAZOSIN HYDROCHLORIDE","activeIngredients":"TERAZOSIN HYDROCHLORIDE","strength":"EQ 5MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TERAZOSIN HYDROCHLORIDE","activeIngredients":"TERAZOSIN HYDROCHLORIDE","strength":"EQ 10MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TERAZOSIN HYDROCHLORIDE","submission":"TERAZOSIN HYDROCHLORIDE","actionType":"EQ 1MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"TERAZOSIN HYDROCHLORIDE","submission":"TERAZOSIN HYDROCHLORIDE","actionType":"EQ 2MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"TERAZOSIN HYDROCHLORIDE","submission":"TERAZOSIN HYDROCHLORIDE","actionType":"EQ 5MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"TERAZOSIN HYDROCHLORIDE","submission":"TERAZOSIN HYDROCHLORIDE","actionType":"EQ 10MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)