ANDA 077571

SUN PHARM INDS INC

FDA Drug Application

Application #077571

Documents

• Letter: 2007-08-14
• Letter: 2013-07-12
• Label: 2013-07-12
• Other: 2013-09-24

Application Sponsors

ANDA 077571

SUN PHARM INDS INC

Marketing Status

• None (Tentative Approval): 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET; ORAL	0.5MG	0	REPAGLINIDE	REPAGLINIDE
002	TABLET;ORAL	1MG	0	REPAGLINIDE	REPAGLINIDE
003	TABLET;ORAL	2MG	0	REPAGLINIDE	REPAGLINIDE

FDA Submissions

	ORIG	1	AP	2013-07-11
LABELING; Labeling	SUPPL	8	AP	2019-10-01	STANDARD
LABELING; Labeling	SUPPL	12	AP	2019-10-01	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	8	Null	15
SUPPL	12	Null	15

TE Codes

002	Prescription	AB
003	Prescription	AB

CDER Filings

SUN PHARM INDS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77571
            [companyName] => SUN PHARM INDS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"REPAGLINIDE","activeIngredients":"REPAGLINIDE","strength":"0.5MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"REPAGLINIDE","activeIngredients":"REPAGLINIDE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"REPAGLINIDE","activeIngredients":"REPAGLINIDE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"07\/11\/2013","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/077571s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"REPAGLINIDE","submission":"REPAGLINIDE","actionType":"0.5MG","submissionClassification":"TABLET; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"REPAGLINIDE","submission":"REPAGLINIDE","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"REPAGLINIDE","submission":"REPAGLINIDE","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2013-07-11
        )

)