NDA 021961

SYNTHON PHARMS

FDA Drug Application

Application #021961

Documents

• Letter: 2007-10-10
• Label: 2007-10-10
• Review: 2009-02-02
• Other Important Information from FDA: 2011-05-26

Application Sponsors

NDA 021961

SYNTHON PHARMS

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004

Application Products

001	TABLET, ORALLY DISINTEGRATING;ORAL	10MG	0	SIMVASTATIN	SIMVASTATIN
002	TABLET, ORALLY DISINTEGRATING;ORAL	20MG	0	SIMVASTATIN	SIMVASTATIN
003	TABLET, ORALLY DISINTEGRATING;ORAL	40MG	0	SIMVASTATIN	SIMVASTATIN
004	TABLET, ORALLY DISINTEGRATING;ORAL	80MG	0	SIMVASTATIN	SIMVASTATIN

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

2007-10-09

STANDARD

Submissions Property Types

ORIG

1

Null

0

CDER Filings

SYNTHON PHARMS

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(
    [0] => Array
        (
            [ApplNo] => 21961
            [companyName] => SYNTHON PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"SIMVASTATIN","activeIngredients":"SIMVASTATIN","strength":"10MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"SIMVASTATIN","activeIngredients":"SIMVASTATIN","strength":"20MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"SIMVASTATIN","activeIngredients":"SIMVASTATIN","strength":"40MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"SIMVASTATIN","activeIngredients":"SIMVASTATIN","strength":"80MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/09\/2007","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021961lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"SIMVASTATIN","submission":"SIMVASTATIN","actionType":"10MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"SIMVASTATIN","submission":"SIMVASTATIN","actionType":"20MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"SIMVASTATIN","submission":"SIMVASTATIN","actionType":"40MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"SIMVASTATIN","submission":"SIMVASTATIN","actionType":"80MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2007-10-09
        )

)