ANDA 078034

BIOCON LIMITED

FDA Drug Application

Application #078034

Documents

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

Application Sponsors

ANDA 078034

BIOCON LIMITED

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	6	AP	2013-03-25
LABELING; Labeling	SUPPL	7	AP	2014-11-05	STANDARD
LABELING; Labeling	SUPPL	8	AP	2014-11-05	STANDARD
LABELING; Labeling	SUPPL	9	AP	2015-10-08	STANDARD
LABELING; Labeling	SUPPL	10	AP	2016-05-05	STANDARD
LABELING; Labeling	SUPPL	12	AP	2019-03-06	STANDARD
LABELING; Labeling	SUPPL	13	AP	2020-07-21	STANDARD
LABELING; Labeling	SUPPL	14	AP	2020-07-21	STANDARD
LABELING; Labeling	SUPPL	16	AP	2022-08-31	STANDARD
LABELING; Labeling	SUPPL	17	AP	2022-08-31	STANDARD

Submissions Property Types

SUPPL	6	Null	15
SUPPL	7	Null	15
SUPPL	8	Null	15
SUPPL	9	Null	7
SUPPL	10	Null	7
SUPPL	12	Null	7
SUPPL	13	Null	7
SUPPL	14	Null	7
SUPPL	16	Null	7
SUPPL	17	Null	7

TE Codes

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

CDER Filings

BIOCON LIMITED

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78034
            [companyName] => BIOCON LIMITED
            [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
        )

)