ANDA 077837

ZYDUS PHARMS USA

FDA Drug Application

Application #077837

Documents

• Other Important Information from FDA: 2011-05-26

Application Sponsors

ANDA 077837

ZYDUS PHARMS USA

Marketing Status

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

Application Products

001	TABLET;ORAL	5MG	0	SIMVASTATIN	SIMVASTATIN
002	TABLET;ORAL	10MG	0	SIMVASTATIN	SIMVASTATIN
003	TABLET;ORAL	20MG	0	SIMVASTATIN	SIMVASTATIN
004	TABLET;ORAL	40MG	0	SIMVASTATIN	SIMVASTATIN
005	TABLET;ORAL	80MG	0	SIMVASTATIN	SIMVASTATIN

FDA Submissions

	ORIG	1	AP	2006-12-20
LABELING; Labeling	SUPPL	2	AP	2008-04-02
LABELING; Labeling	SUPPL	9	AP	2008-01-16
LABELING; Labeling	SUPPL	15	AP	2008-11-18
LABELING; Labeling	SUPPL	18	AP	2010-09-08
LABELING; Labeling	SUPPL	19	AP	2011-03-16
LABELING; Labeling	SUPPL	22	AP	2011-07-25
LABELING; Labeling	SUPPL	24	AP	2011-11-04
LABELING; Labeling	SUPPL	25	AP	2012-03-29
LABELING; Labeling	SUPPL	27	AP	2013-02-28	STANDARD
LABELING; Labeling	SUPPL	29	AP	2014-11-03	STANDARD
LABELING; Labeling	SUPPL	30	AP	2014-11-03	STANDARD
LABELING; Labeling	SUPPL	35	AP	2015-10-05	STANDARD
LABELING; Labeling	SUPPL	38	AP	2019-08-07	STANDARD
LABELING; Labeling	SUPPL	39	AP	2019-08-07	STANDARD
LABELING; Labeling	SUPPL	40	AP	2020-05-14	STANDARD
LABELING; Labeling	SUPPL	41	AP	2022-08-31	STANDARD
LABELING; Labeling	SUPPL	42	AP	2022-08-31	STANDARD

Submissions Property Types

SUPPL	24	Null	15
SUPPL	25	Null	15
SUPPL	27	Null	15
SUPPL	29	Null	7
SUPPL	30	Null	7
SUPPL	35	Null	7
SUPPL	38	Null	15
SUPPL	39	Null	15
SUPPL	40	Null	7
SUPPL	41	Null	7
SUPPL	42	Null	7

TE Codes

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

CDER Filings

ZYDUS PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77837
            [companyName] => ZYDUS PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"SIMVASTATIN","activeIngredients":"SIMVASTATIN","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SIMVASTATIN","activeIngredients":"SIMVASTATIN","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SIMVASTATIN","activeIngredients":"SIMVASTATIN","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SIMVASTATIN","activeIngredients":"SIMVASTATIN","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SIMVASTATIN","activeIngredients":"SIMVASTATIN","strength":"80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SIMVASTATIN","submission":"SIMVASTATIN","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"SIMVASTATIN","submission":"SIMVASTATIN","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"SIMVASTATIN","submission":"SIMVASTATIN","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"SIMVASTATIN","submission":"SIMVASTATIN","actionType":"40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"SIMVASTATIN","submission":"SIMVASTATIN","actionType":"80MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)