ANDA 075522

DEXCEL LTD

FDA Drug Application

Application #075522

Documents

• Letter: 2000-04-17
• Review: 2000-04-17

Application Sponsors

ANDA 075522

DEXCEL LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

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

FDA Submissions

	ORIG	1	AP	2000-04-17
LABELING; Labeling	SUPPL	3	AP	2000-12-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2001-04-04
LABELING; Labeling	SUPPL	5	AP	2001-04-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2001-09-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2002-02-19
LABELING; Labeling	SUPPL	8	AP	2002-02-19
LABELING; Labeling	SUPPL	9	AP	2004-03-24
LABELING; Labeling	SUPPL	11	AP	2011-04-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2014-10-31
LABELING; Labeling	SUPPL	22	AP	2022-01-26	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	11	Null	7
SUPPL	12	Null	15
SUPPL	22	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

DEXCEL LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75522
            [companyName] => DEXCEL LTD
            [docInserts] => ["",""]
            [products] => [{"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":"30MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"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":"30MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)