ANDA 075135

UPSHER SMITH LABS

FDA Drug Application

Application #075135

Documents

• Letter: 1999-12-02
• Letter: 2000-02-01
• Review: 1999-05-28
• Review: 2002-10-29
• Review: 2002-10-29
• Review: 2002-10-29
• Review: 2002-10-29
• Other Important Information from FDA: 2005-08-01
• Letter: 1998-04-30
• Letter: 1998-04-30
• Letter: 1999-09-24
• Label: 1998-04-30
• Review: 2002-10-29
• Review: 2002-10-29
• Review: 2002-10-29
• Medication Guide: 2009-11-20

Application Sponsors

ANDA 075135

UPSHER SMITH LABS

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	200MG	0	PACERONE	AMIODARONE HYDROCHLORIDE
002	TABLET;ORAL	100MG	0	PACERONE	AMIODARONE HYDROCHLORIDE
003	TABLET;ORAL	400MG	0	PACERONE	AMIODARONE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1998-04-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1999-12-02
LABELING; Labeling	SUPPL	3	AP	1999-09-24
BIOEQUIV; Bioequivalence	SUPPL	4	AP	2000-02-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2000-04-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2000-04-12
LABELING; Labeling	SUPPL	7	AP	2000-04-12
LABELING; Labeling	SUPPL	8	AP	2002-08-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2002-12-19
LABELING; Labeling	SUPPL	11	AP	2005-04-12
LABELING; Labeling	SUPPL	13	AP	2003-09-24
LABELING; Labeling	SUPPL	16	AP	2004-01-05
LABELING; Labeling	SUPPL	17	AP	2004-10-04
LABELING; Labeling	SUPPL	18	AP	2006-02-13
LABELING; Labeling	SUPPL	25	AP	2006-04-04
LABELING; Labeling	SUPPL	26	AP	2019-11-01
LABELING; Labeling	SUPPL	27	AP	2019-11-01
LABELING; Labeling	SUPPL	34	AP	2007-11-16
LABELING; Labeling	SUPPL	35	AP	2019-11-01
LABELING; Labeling	SUPPL	39	AP	2009-04-28
LABELING; Labeling	SUPPL	40	AP	2009-12-01
LABELING; Labeling	SUPPL	41	AP	2010-11-30
LABELING; Labeling	SUPPL	43	AP	2013-06-17
LABELING; Labeling	SUPPL	44	AP	2013-06-17
LABELING; Labeling	SUPPL	45	AP	2015-08-13	STANDARD
LABELING; Labeling	SUPPL	46	AP	2015-08-13	STANDARD
LABELING; Labeling	SUPPL	47	AP	2015-08-13	STANDARD
LABELING; Labeling	SUPPL	48	AP	2015-08-13	STANDARD
LABELING; Labeling	SUPPL	49	AP	2019-11-01	STANDARD
LABELING; Labeling	SUPPL	51	AP	2019-11-01	STANDARD
LABELING; Labeling	SUPPL	52	AP	2019-11-01	STANDARD
LABELING; Labeling	SUPPL	54	AP	2019-11-01	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	13
SUPPL	9	Null	0
SUPPL	26	Null	15
SUPPL	27	Null	15
SUPPL	35	Null	15
SUPPL	40	Null	8
SUPPL	41	Null	7
SUPPL	43	Null	15
SUPPL	44	Null	15
SUPPL	45	Null	15
SUPPL	46	Null	15
SUPPL	47	Null	7
SUPPL	48	Null	7
SUPPL	49	Null	7
SUPPL	51	Null	7
SUPPL	52	Null	7
SUPPL	54	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75135
            [companyName] => UPSHER SMITH LABS
            [docInserts] => ["Medication Guide","http:\/\/www.fda.gov\/downloads\/Drugs\/DrugSafety\/ucm088668.pdf"]
            [products] => [{"drugName":"PACERONE","activeIngredients":"AMIODARONE HYDROCHLORIDE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PACERONE","activeIngredients":"AMIODARONE HYDROCHLORIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"04\/30\/1998","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/anda\\\/98\\\/75135ap_appltr_prntlbl_chemr.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"PACERONE","submission":"AMIODARONE HYDROCHLORIDE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PACERONE","submission":"AMIODARONE HYDROCHLORIDE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1998-04-30
        )

)