NDA 021392

BAUSCH

FDA Drug Application

Application #021392

Documents

• Letter: 2007-05-01
• Label: 2003-02-06
• Label: 2004-04-05
• Label: 2007-05-01
• Label: 2015-04-14
• Review: 2005-06-27
• Review: 2007-07-06
• Letter: 2004-04-07
• Letter: 2010-11-30
• Letter: 2015-03-25
• Label: 2010-11-22
• Letter: 2016-11-22
• Label: 2016-11-21

Application Sponsors

NDA 021392

BAUSCH

Marketing Status

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

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	120MG	1	CARDIZEM LA	DILTIAZEM HYDROCHLORIDE
002	TABLET, EXTENDED RELEASE;ORAL	180MG	1	CARDIZEM LA	DILTIAZEM HYDROCHLORIDE
003	TABLET, EXTENDED RELEASE;ORAL	240MG	1	CARDIZEM LA	DILTIAZEM HYDROCHLORIDE
004	TABLET, EXTENDED RELEASE;ORAL	300MG	1	CARDIZEM LA	DILTIAZEM HYDROCHLORIDE
005	TABLET, EXTENDED RELEASE;ORAL	360MG	1	CARDIZEM LA	DILTIAZEM HYDROCHLORIDE
006	TABLET, EXTENDED RELEASE;ORAL	420MG	1	CARDIZEM LA	DILTIAZEM HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2003-02-06	STANDARD
EFFICACY; Efficacy	SUPPL	2	AP	2004-04-02	STANDARD
LABELING; Labeling	SUPPL	10	AP	2007-04-27	STANDARD
LABELING; Labeling	SUPPL	14	AP	2010-11-23	UNKNOWN
LABELING; Labeling	SUPPL	19	AP	2015-03-23	STANDARD
LABELING; Labeling	SUPPL	20	AP	2016-11-18	STANDARD

Submissions Property Types

SUPPL	14	Null	7
SUPPL	19	Null	7
SUPPL	20	Null	7

TE Codes

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

CDER Filings

BAUSCH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21392
            [companyName] => BAUSCH
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARDIZEM LA","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"120MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"CARDIZEM LA","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"180MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"CARDIZEM LA","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"240MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"CARDIZEM LA","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"300MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"CARDIZEM LA","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"360MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"CARDIZEM LA","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"420MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"11\/18\/2016","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021392s020lbl.pdf\"}]","notes":""},{"actionDate":"03\/23\/2015","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021392s019lbl.pdf\"}]","notes":""},{"actionDate":"11\/23\/2010","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021392s014lbl.pdf\"}]","notes":""},{"actionDate":"04\/27\/2007","submission":"SUPPL-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021392s010lbl.pdf\"}]","notes":""},{"actionDate":"04\/02\/2004","submission":"SUPPL-2","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21392se1-002_cardizem_lbl.pdf\"}]","notes":""},{"actionDate":"02\/06\/2003","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/021392lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CARDIZEM LA","submission":"DILTIAZEM HYDROCHLORIDE","actionType":"120MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"CARDIZEM LA","submission":"DILTIAZEM HYDROCHLORIDE","actionType":"180MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"CARDIZEM LA","submission":"DILTIAZEM HYDROCHLORIDE","actionType":"240MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"CARDIZEM LA","submission":"DILTIAZEM HYDROCHLORIDE","actionType":"300MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"CARDIZEM LA","submission":"DILTIAZEM HYDROCHLORIDE","actionType":"360MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"CARDIZEM LA","submission":"DILTIAZEM HYDROCHLORIDE","actionType":"420MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2016-11-18
        )

)