LILLY FDA Approval NDA 021318

NDA 021318

LILLY

FDA Drug Application

Application #021318

Documents

Letter2004-06-07
Letter2009-07-23
Letter2008-03-04
Letter2008-06-30
Letter2011-08-12
Letter2013-09-04
Label2001-11-26
Label2004-06-07
Label2007-05-29
Label2008-03-05
Label2013-09-09
Review2004-03-24
Medication Guide2003-12-17
Letter2001-11-26
Letter2004-09-07
Letter2007-05-29
Letter2012-03-15
Label2004-09-07
Label2009-07-23
Review2011-10-10
Letter2017-05-02
Label2019-10-04
Letter2019-10-04
Letter2020-04-07
Label2020-04-09
Letter2020-11-18
Label2020-12-01
Medication Guide2021-02-05
Letter2021-09-09
Label2021-09-20
Review2021-12-20
Review2021-12-20
Review2022-06-28

Application Sponsors

NDA 021318LILLY

Marketing Status

Discontinued001
Prescription002

Application Products

001SOLUTION;SUBCUTANEOUS0.75MG/3ML (0.25MG/ML)0FORTEOTERIPARATIDE
002SOLUTION;SUBCUTANEOUS0.6MG/2.4ML (0.25MG/ML)1FORTEOTERIPARATIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2002-11-26STANDARD
LABELING; LabelingSUPPL2AP2004-06-02STANDARD
LABELING; LabelingSUPPL4AP2004-09-03STANDARD
LABELING; LabelingSUPPL9AP2007-05-19STANDARD
EFFICACY; EfficacySUPPL12AP2009-07-22STANDARD
LABELING; LabelingSUPPL15AP2008-02-28STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL16AP2008-06-25N/A
LABELING; LabelingSUPPL26AP2011-08-10UNKNOWN
LABELING; LabelingSUPPL27AP2012-03-13STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL32AP2013-02-15STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL33AP2013-03-13STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL35AP2013-08-02STANDARD
REMS; REMSSUPPL36AP2013-08-30N/A
MANUF (CMC); Manufacturing (CMC)SUPPL37AP2014-03-05STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL38AP2014-01-24STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL39AP2014-04-11STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL40AP2014-08-13STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL41AP2014-09-12STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL44AP2015-11-23STANDARD
REMS; REMSSUPPL51AP2017-04-28N/A
LABELING; LabelingSUPPL52AP2019-10-03STANDARD
LABELING; LabelingSUPPL53AP2020-04-06STANDARD
EFFICACY; EfficacySUPPL54AP2020-11-16STANDARD
LABELING; LabelingSUPPL56AP2021-09-07STANDARD

Submissions Property Types

SUPPL12Null7
SUPPL26Null6
SUPPL27Null6
SUPPL32Null0
SUPPL33Null0
SUPPL35Null0
SUPPL36Null15
SUPPL37Null0
SUPPL38Null0
SUPPL39Null0
SUPPL40Null0
SUPPL41Null0
SUPPL44Null0
SUPPL51Null6
SUPPL52Null33
SUPPL53Null7
SUPPL54Null15
SUPPL56Null15

CDER Filings

LILLY
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21318
            [companyName] => LILLY
            [docInserts] => ["Medication Guide","http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/021318Orig1s054lbl.pdf#page=16"]
            [products] => [{"drugName":"FORTEO","activeIngredients":"TERIPARATIDE","strength":"0.75MG\/3ML (0.25MG\/ML)","dosageForm":"SOLUTION;SUBCUTANEOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FORTEO","activeIngredients":"TERIPARATIDE","strength":"0.6MG\/2.4ML (0.25MG\/ML)","dosageForm":"SOLUTION;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"09\/07\/2021","submission":"SUPPL-56","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/021318Orig1s056lbl.pdf\"}]","notes":""},{"actionDate":"09\/07\/2021","submission":"SUPPL-56","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/021318Orig1s056lbl.pdf\"}]","notes":""},{"actionDate":"11\/16\/2020","submission":"SUPPL-54","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021318Orig1s054lbl.pdf\"}]","notes":""},{"actionDate":"04\/06\/2020","submission":"SUPPL-53","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021318s053lbl.pdf\"}]","notes":""},{"actionDate":"04\/06\/2020","submission":"SUPPL-53","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021318s053lbl.pdf\"}]","notes":""},{"actionDate":"10\/03\/2019","submission":"SUPPL-52","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021318s052lbl.pdf\"}]","notes":""},{"actionDate":"08\/30\/2013","submission":"SUPPL-36","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021318s036lbl.pdf\"}]","notes":""},{"actionDate":"07\/22\/2009","submission":"SUPPL-12","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021318s012lbl.pdf\"}]","notes":""},{"actionDate":"07\/22\/2009","submission":"SUPPL-12","supplementCategories":"REMS-Proposal","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021318s012lbl.pdf\"}]","notes":""},{"actionDate":"02\/28\/2008","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021318s015lbl.pdf\"}]","notes":""},{"actionDate":"05\/19\/2007","submission":"SUPPL-9","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021318s009lbl.pdf\"}]","notes":""},{"actionDate":"09\/03\/2004","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21318s004lbl.pdf\"}]","notes":""},{"actionDate":"06\/02\/2004","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21318slr002_forteo_lbl.pdf\"}]","notes":""},{"actionDate":"11\/26\/2002","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/21318_forteo_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"FORTEO","submission":"TERIPARATIDE","actionType":"0.75MG\/3ML (0.25MG\/ML)","submissionClassification":"SOLUTION;SUBCUTANEOUS","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"FORTEO","submission":"TERIPARATIDE","actionType":"0.6MG\/2.4ML (0.25MG\/ML)","submissionClassification":"SOLUTION;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2021-09-07
        )

)
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