ANDA 075967

SUN PHARM INDS INC

FDA Drug Application

Application #075967

Application Sponsors

ANDA 075967

SUN PHARM INDS INC

Marketing Status

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

Application Products

001	TABLET;ORAL	500MG	0	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE
002	TABLET;ORAL	850MG	0	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE
003	TABLET;ORAL	1GM	0	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2002-01-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2002-08-23
LABELING; Labeling	SUPPL	3	AP	2002-08-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2002-12-16
LABELING; Labeling	SUPPL	5	AP	2002-12-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2002-11-01
LABELING; Labeling	SUPPL	10	AP	2005-02-14
LABELING; Labeling	SUPPL	15	AP	2006-07-07
LABELING; Labeling	SUPPL	17	AP	2007-04-17
LABELING; Labeling	SUPPL	20	AP	2007-09-04
LABELING; Labeling	SUPPL	23	AP	2007-07-11
LABELING; Labeling	SUPPL	25	AP	2008-09-30
LABELING; Labeling	SUPPL	37	AP	2019-11-04	STANDARD
LABELING; Labeling	SUPPL	38	AP	2019-11-04	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	37	Null	7
SUPPL	38	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

SUN PHARM INDS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75967
            [companyName] => SUN PHARM INDS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"METFORMIN HYDROCHLORIDE","activeIngredients":"METFORMIN HYDROCHLORIDE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METFORMIN HYDROCHLORIDE","activeIngredients":"METFORMIN HYDROCHLORIDE","strength":"850MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METFORMIN HYDROCHLORIDE","activeIngredients":"METFORMIN HYDROCHLORIDE","strength":"1GM","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METFORMIN HYDROCHLORIDE","submission":"METFORMIN HYDROCHLORIDE","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"METFORMIN HYDROCHLORIDE","submission":"METFORMIN HYDROCHLORIDE","actionType":"850MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"METFORMIN HYDROCHLORIDE","submission":"METFORMIN HYDROCHLORIDE","actionType":"1GM","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)