ANDA 075401

ACTAVIS LABS FL INC

FDA Drug Application

Application #075401

Documents

• Letter: 2004-06-18
• Review: 2005-07-22

Application Sponsors

ANDA 075401

ACTAVIS LABS FL INC

Marketing Status

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

Application Products

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

FDA Submissions

	ORIG	1	AP	2003-04-10
LABELING; Labeling	SUPPL	11	AP	2008-07-29
LABELING; Labeling	SUPPL	20	AP	2011-11-30

Submissions Property Types

SUPPL

20

Null

15

TE Codes

001	Prescription	AB4
002	Prescription	AB4
003	Prescription	AB4
004	Prescription	AB4
005	Prescription	AB4

CDER Filings

ACTAVIS LABS FL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75401
            [companyName] => ACTAVIS LABS FL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TAZTIA XT","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"120MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TAZTIA XT","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"180MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TAZTIA XT","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"240MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TAZTIA XT","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"300MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TAZTIA XT","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"360MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TAZTIA XT","submission":"DILTIAZEM HYDROCHLORIDE","actionType":"120MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"TAZTIA XT","submission":"DILTIAZEM HYDROCHLORIDE","actionType":"180MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"TAZTIA XT","submission":"DILTIAZEM HYDROCHLORIDE","actionType":"240MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"TAZTIA XT","submission":"DILTIAZEM HYDROCHLORIDE","actionType":"300MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"TAZTIA XT","submission":"DILTIAZEM HYDROCHLORIDE","actionType":"360MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)