ANDA 076363

SUN PHARM INDS INC

FDA Drug Application

Application #076363

Application Sponsors

ANDA 076363

SUN PHARM INDS INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	0.125MG	0	DIGOXIN	DIGOXIN
002	TABLET;ORAL	0.25MG	0	DIGOXIN	DIGOXIN

FDA Submissions

	ORIG	1	AP	2003-01-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2007-06-14
LABELING; Labeling	SUPPL	12	AP	2010-07-06
LABELING; Labeling	SUPPL	19	AP	2020-10-07	STANDARD
LABELING; Labeling	SUPPL	22	AP	2020-10-07	STANDARD
LABELING; Labeling	SUPPL	25	AP	2020-10-07	STANDARD
LABELING; Labeling	SUPPL	26	AP	2020-10-07	STANDARD
LABELING; Labeling	SUPPL	30	AP	2020-10-07	STANDARD
LABELING; Labeling	SUPPL	32	AP	2020-10-07	STANDARD

Submissions Property Types

SUPPL	8	Null	0
SUPPL	12	Null	7
SUPPL	19	Null	7
SUPPL	22	Null	15
SUPPL	25	Null	7
SUPPL	26	Null	15
SUPPL	30	Null	15
SUPPL	32	Null	31

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

SUN PHARM INDS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76363
            [companyName] => SUN PHARM INDS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIGOXIN","activeIngredients":"DIGOXIN","strength":"0.125MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DIGOXIN","activeIngredients":"DIGOXIN","strength":"0.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DIGOXIN","submission":"DIGOXIN","actionType":"0.125MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DIGOXIN","submission":"DIGOXIN","actionType":"0.25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)