ANDA 076563

NESHER PHARMS

FDA Drug Application

Application #076563

Documents

• Letter: 2006-09-15

Application Sponsors

ANDA 076563

NESHER PHARMS

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004
• Discontinued: 005
• Discontinued: 006

Application Products

001	CAPSULE, EXTENDED RELEASE;ORAL	420MG	0	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE
002	CAPSULE, EXTENDED RELEASE;ORAL	120MG	0	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE
003	CAPSULE, EXTENDED RELEASE;ORAL	180MG	0	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE
004	CAPSULE, EXTENDED RELEASE;ORAL	240MG	0	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE
005	CAPSULE, EXTENDED RELEASE;ORAL	300MG	0	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE
006	CAPSULE, EXTENDED RELEASE;ORAL	360MG	0	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2006-09-12
LABELING; Labeling	SUPPL	5	AP	2008-08-25
LABELING; Labeling	SUPPL	11	AP	2007-10-15

CDER Filings

NESHER PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76563
            [companyName] => NESHER PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DILTIAZEM HYDROCHLORIDE","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"420MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DILTIAZEM HYDROCHLORIDE","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"120MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DILTIAZEM HYDROCHLORIDE","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"180MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DILTIAZEM HYDROCHLORIDE","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"240MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DILTIAZEM HYDROCHLORIDE","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"300MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DILTIAZEM HYDROCHLORIDE","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"360MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DILTIAZEM HYDROCHLORIDE","submission":"DILTIAZEM HYDROCHLORIDE","actionType":"420MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DILTIAZEM HYDROCHLORIDE","submission":"DILTIAZEM HYDROCHLORIDE","actionType":"120MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DILTIAZEM HYDROCHLORIDE","submission":"DILTIAZEM HYDROCHLORIDE","actionType":"180MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DILTIAZEM HYDROCHLORIDE","submission":"DILTIAZEM HYDROCHLORIDE","actionType":"240MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DILTIAZEM HYDROCHLORIDE","submission":"DILTIAZEM HYDROCHLORIDE","actionType":"300MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DILTIAZEM HYDROCHLORIDE","submission":"DILTIAZEM HYDROCHLORIDE","actionType":"360MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)