ANDA 070322

INNOGENIX

FDA Drug Application

Application #070322

Application Sponsors

ANDA 070322

INNOGENIX

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005

Application Products

001	TABLET;ORAL	80MG	0	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE
002	TABLET;ORAL	10MG	0	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE
003	TABLET;ORAL	20MG	0	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE
004	TABLET;ORAL	40MG	0	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE
005	TABLET;ORAL	60MG	0	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1986-08-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1987-03-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1987-12-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1987-12-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1987-12-23
LABELING; Labeling	SUPPL	8	AP	1988-08-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1989-09-07
LABELING; Labeling	SUPPL	11	AP	1991-06-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1991-08-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1992-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1992-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1994-10-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1994-12-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1998-12-01
LABELING; Labeling	SUPPL	19	AP	1998-08-04

Submissions Property Types

SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0

TE Codes

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

CDER Filings

INNOGENIX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 70322
            [companyName] => INNOGENIX
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROPRANOLOL HYDROCHLORIDE","activeIngredients":"PROPRANOLOL HYDROCHLORIDE","strength":"80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PROPRANOLOL HYDROCHLORIDE","activeIngredients":"PROPRANOLOL HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PROPRANOLOL HYDROCHLORIDE","activeIngredients":"PROPRANOLOL HYDROCHLORIDE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PROPRANOLOL HYDROCHLORIDE","activeIngredients":"PROPRANOLOL HYDROCHLORIDE","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PROPRANOLOL HYDROCHLORIDE","activeIngredients":"PROPRANOLOL HYDROCHLORIDE","strength":"60MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PROPRANOLOL HYDROCHLORIDE","submission":"PROPRANOLOL HYDROCHLORIDE","actionType":"80MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PROPRANOLOL HYDROCHLORIDE","submission":"PROPRANOLOL HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PROPRANOLOL HYDROCHLORIDE","submission":"PROPRANOLOL HYDROCHLORIDE","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PROPRANOLOL HYDROCHLORIDE","submission":"PROPRANOLOL HYDROCHLORIDE","actionType":"40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PROPRANOLOL HYDROCHLORIDE","submission":"PROPRANOLOL HYDROCHLORIDE","actionType":"60MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)