ANDA 077686

ACTAVIS LABS FL INC

FDA Drug Application

Application #077686

Application Sponsors

ANDA 077686

ACTAVIS LABS FL INC

Marketing Status

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

Application Products

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

FDA Submissions

	ORIG	1	AP	2010-03-15
LABELING; Labeling	SUPPL	5	AP	2011-04-21
LABELING; Labeling	SUPPL	10	AP	2016-11-08	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	10	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB
005	Prescription	AB
006	Prescription	AB

CDER Filings

ACTAVIS LABS FL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77686
            [companyName] => ACTAVIS LABS FL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DILTIAZEM HYDROCHLORIDE","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"420MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DILTIAZEM HYDROCHLORIDE","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"360MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DILTIAZEM HYDROCHLORIDE","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"300MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DILTIAZEM HYDROCHLORIDE","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"240MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DILTIAZEM HYDROCHLORIDE","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"180MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DILTIAZEM HYDROCHLORIDE","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"120MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DILTIAZEM HYDROCHLORIDE","submission":"DILTIAZEM HYDROCHLORIDE","actionType":"420MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DILTIAZEM HYDROCHLORIDE","submission":"DILTIAZEM HYDROCHLORIDE","actionType":"360MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DILTIAZEM HYDROCHLORIDE","submission":"DILTIAZEM HYDROCHLORIDE","actionType":"300MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DILTIAZEM HYDROCHLORIDE","submission":"DILTIAZEM HYDROCHLORIDE","actionType":"240MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DILTIAZEM HYDROCHLORIDE","submission":"DILTIAZEM HYDROCHLORIDE","actionType":"180MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DILTIAZEM HYDROCHLORIDE","submission":"DILTIAZEM HYDROCHLORIDE","actionType":"120MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)