NDA 021402

ABBVIE

FDA Drug Application

Application #021402

Documents

• Letter: 2012-10-02
• Label: 2002-07-24
• Label: 2008-07-15
• Label: 2014-01-15
• Letter: 2002-07-24
• Letter: 2008-07-15
• Label: 2008-06-05
• Review: 2002-11-25
• Label: 2017-02-24
• Label: 2017-02-24
• Letter: 2017-03-02
• Letter: 2017-03-02
• Label: 2020-07-16
• Letter: 2020-07-20
• Letter: 2022-08-31
• Label: 2022-08-31

Application Sponsors

NDA 021402

ABBVIE

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 006
• Prescription: 007
• Prescription: 008
• Prescription: 009
• Prescription: 010
• Prescription: 011
• Prescription: 012

Application Products

001	TABLET;ORAL	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	1	SYNTHROID	LEVOTHYROXINE SODIUM
002	TABLET;ORAL	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	1	SYNTHROID	LEVOTHYROXINE SODIUM
003	TABLET;ORAL	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	1	SYNTHROID	LEVOTHYROXINE SODIUM
004	TABLET;ORAL	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	1	SYNTHROID	LEVOTHYROXINE SODIUM
005	TABLET;ORAL	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	1	SYNTHROID	LEVOTHYROXINE SODIUM
006	TABLET;ORAL	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	1	SYNTHROID	LEVOTHYROXINE SODIUM
007	TABLET;ORAL	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	1	SYNTHROID	LEVOTHYROXINE SODIUM
008	TABLET;ORAL	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	1	SYNTHROID	LEVOTHYROXINE SODIUM
009	TABLET;ORAL	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	1	SYNTHROID	LEVOTHYROXINE SODIUM
010	TABLET;ORAL	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	1	SYNTHROID	LEVOTHYROXINE SODIUM
011	TABLET;ORAL	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	1	SYNTHROID	LEVOTHYROXINE SODIUM
012	TABLET;ORAL	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	1	SYNTHROID	LEVOTHYROXINE SODIUM

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2002-07-24	STANDARD
LABELING; Labeling	SUPPL	11	AP	2008-04-20	STANDARD
LABELING; Labeling	SUPPL	17	AP	2008-07-14	STANDARD
LABELING; Labeling	SUPPL	20	AP	2011-01-14	UNKNOWN
LABELING; Labeling	SUPPL	24	AP	2017-02-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	2014-05-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	2014-04-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	2015-04-15	STANDARD
LABELING; Labeling	SUPPL	28	AP	2017-02-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	2015-11-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	2016-05-13	STANDARD
LABELING; Labeling	SUPPL	34	AP	2020-07-15	STANDARD
LABELING; Labeling	SUPPL	36	AP	2022-08-30	STANDARD

Submissions Property Types

ORIG	1	Null	31
SUPPL	20	Null	6
SUPPL	24	Null	15
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	15
SUPPL	29	Null	0
SUPPL	30	Null	0
SUPPL	34	Null	6
SUPPL	36	Null	15

TE Codes

001	Prescription	AB1
002	Prescription	AB1
003	Prescription	AB1
004	Prescription	AB1
005	Prescription	AB1
006	Prescription	AB1
007	Prescription	AB1
008	Prescription	AB1
009	Prescription	AB1
010	Prescription	AB1
011	Prescription	AB1
012	Prescription	AB1

CDER Filings

ABBVIE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21402
            [companyName] => ABBVIE
            [docInserts] => ["",""]
            [products] => [{"drugName":"SYNTHROID","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"SYNTHROID","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"SYNTHROID","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"SYNTHROID","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"SYNTHROID","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"SYNTHROID","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"SYNTHROID","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"SYNTHROID","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"SYNTHROID","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"SYNTHROID","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"SYNTHROID","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"SYNTHROID","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"07\/15\/2020","submission":"SUPPL-34","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021402s034lbl.pdf\"}]","notes":""},{"actionDate":"02\/23\/2017","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021402s024s028lbl.pdf\"}]","notes":""},{"actionDate":"02\/23\/2017","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021402s024s028lbl.pdf\"}]","notes":""},{"actionDate":"01\/14\/2011","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021402s020lbl.pdf\"}]","notes":""},{"actionDate":"07\/14\/2008","submission":"SUPPL-17","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021402s017lbl.pdf\"}]","notes":""},{"actionDate":"04\/20\/2008","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021402s011lbl.pdf\"}]","notes":""},{"actionDate":"07\/24\/2002","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/21402lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"SYNTHROID","submission":"LEVOTHYROXINE SODIUM","actionType":"0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"SYNTHROID","submission":"LEVOTHYROXINE SODIUM","actionType":"0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"SYNTHROID","submission":"LEVOTHYROXINE SODIUM","actionType":"0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"SYNTHROID","submission":"LEVOTHYROXINE SODIUM","actionType":"0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"SYNTHROID","submission":"LEVOTHYROXINE SODIUM","actionType":"0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"SYNTHROID","submission":"LEVOTHYROXINE SODIUM","actionType":"0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"SYNTHROID","submission":"LEVOTHYROXINE SODIUM","actionType":"0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"SYNTHROID","submission":"LEVOTHYROXINE SODIUM","actionType":"0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"SYNTHROID","submission":"LEVOTHYROXINE SODIUM","actionType":"0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"SYNTHROID","submission":"LEVOTHYROXINE SODIUM","actionType":"0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"SYNTHROID","submission":"LEVOTHYROXINE SODIUM","actionType":"0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"SYNTHROID","submission":"LEVOTHYROXINE SODIUM","actionType":"0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-07-15
        )

)