ANDA 075215

INNOGENIX

FDA Drug Application

Application #075215

Documents

• Letter: 1999-07-29

Application Sponsors

ANDA 075215

INNOGENIX

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	100MG	0	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE
002	TABLET;ORAL	200MG	0	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE
003	TABLET;ORAL	300MG	0	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1999-07-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2000-05-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2000-10-02
LABELING; Labeling	SUPPL	4	AP	2000-10-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2001-11-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2002-01-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2002-09-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2002-12-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2015-02-23

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	18	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

INNOGENIX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75215
            [companyName] => INNOGENIX
            [docInserts] => ["",""]
            [products] => [{"drugName":"LABETALOL HYDROCHLORIDE","activeIngredients":"LABETALOL HYDROCHLORIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LABETALOL HYDROCHLORIDE","activeIngredients":"LABETALOL HYDROCHLORIDE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LABETALOL HYDROCHLORIDE","activeIngredients":"LABETALOL HYDROCHLORIDE","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LABETALOL HYDROCHLORIDE","submission":"LABETALOL HYDROCHLORIDE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LABETALOL HYDROCHLORIDE","submission":"LABETALOL HYDROCHLORIDE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LABETALOL HYDROCHLORIDE","submission":"LABETALOL HYDROCHLORIDE","actionType":"300MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)