ANDA 205366

PAR STERILE PRODUCTS

FDA Drug Application

Application #205366

Documents

• Letter: 2015-12-09
• Label: 2015-12-11

Application Sponsors

ANDA 205366

PAR STERILE PRODUCTS

Marketing Status

• Discontinued: 001

Application Products

001

POWDER;INTRAVENOUS

200MCG/VIAL

0

LEVOTHYROXINE SODIUM

LEVOTHYROXINE SODIUM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2015-12-07	STANDARD
UNKNOWN;	ORIG	2	TA	2015-12-07	STANDARD

Submissions Property Types

ORIG	1	Null	15
ORIG	2	Null	1

CDER Filings

PAR STERILE PRODUCTS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205366
            [companyName] => PAR STERILE PRODUCTS
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"200MCG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"12\/07\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205366Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/07\/2015","submission":"ORIG-2","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/07\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205366Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/205366Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2015-12-07
        )

)