ANDA 075395

NESHER PHARMS

FDA Drug Application

Application #075395

Documents

• Letter: 2000-03-16

Application Sponsors

ANDA 075395

NESHER PHARMS

Marketing Status

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

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	30MG	0	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE
002	TABLET, EXTENDED RELEASE;ORAL	60MG	0	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE
003	TABLET, EXTENDED RELEASE;ORAL	120MG	0	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE

FDA Submissions

	ORIG	1	AP	2000-03-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2001-03-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2002-02-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2002-08-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2002-09-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2002-09-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2007-06-14
LABELING; Labeling	SUPPL	13	AP	2007-06-14
LABELING; Labeling	SUPPL	18	AP	2007-10-31
LABELING; Labeling	SUPPL	25	AP	2015-03-04

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	12	Null	0
SUPPL	25	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

NESHER PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75395
            [companyName] => NESHER PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISOSORBIDE MONONITRATE","activeIngredients":"ISOSORBIDE MONONITRATE","strength":"30MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ISOSORBIDE MONONITRATE","activeIngredients":"ISOSORBIDE MONONITRATE","strength":"60MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ISOSORBIDE MONONITRATE","activeIngredients":"ISOSORBIDE MONONITRATE","strength":"120MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ISOSORBIDE MONONITRATE","submission":"ISOSORBIDE MONONITRATE","actionType":"30MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ISOSORBIDE MONONITRATE","submission":"ISOSORBIDE MONONITRATE","actionType":"60MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ISOSORBIDE MONONITRATE","submission":"ISOSORBIDE MONONITRATE","actionType":"120MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)