ANDA 075998

SUN PHARM INDUSTRIES

FDA Drug Application

Application #075998

Documents

• Letter: 2003-04-10

Application Sponsors

ANDA 075998

SUN PHARM INDUSTRIES

Marketing Status

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

Application Products

001	TABLET;ORAL	150MG	0	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE
002	TABLET;ORAL	225MG	0	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE
003	TABLET;ORAL	300MG	0	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2001-11-29
LABELING; Labeling	SUPPL	5	AP	2003-10-24
LABELING; Labeling	SUPPL	20	AP	2019-10-31	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	20	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

SUN PHARM INDUSTRIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75998
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROPAFENONE HYDROCHLORIDE","activeIngredients":"PROPAFENONE HYDROCHLORIDE","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PROPAFENONE HYDROCHLORIDE","activeIngredients":"PROPAFENONE HYDROCHLORIDE","strength":"225MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PROPAFENONE HYDROCHLORIDE","activeIngredients":"PROPAFENONE HYDROCHLORIDE","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PROPAFENONE HYDROCHLORIDE","submission":"PROPAFENONE HYDROCHLORIDE","actionType":"150MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PROPAFENONE HYDROCHLORIDE","submission":"PROPAFENONE HYDROCHLORIDE","actionType":"225MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PROPAFENONE HYDROCHLORIDE","submission":"PROPAFENONE HYDROCHLORIDE","actionType":"300MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)