NDA 021116

ALVOGEN

FDA Drug Application

Application #021116

Documents

• Letter: 2006-03-23
• Review: 2004-08-10
• Letter: 2002-10-24
• Letter: 2016-05-24
• Label: 2002-10-24
• Label: 2006-03-14
• Letter: 2017-09-01
• Label: 2017-09-01
• Label: 2019-04-25
• Letter: 2019-04-26
• Letter: 2021-12-16
• Letter: 2022-04-15

Application Sponsors

NDA 021116

ALVOGEN

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

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2002-10-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2004-12-07	STANDARD
LABELING; Labeling	SUPPL	6	AP	2006-03-10	STANDARD
LABELING; Labeling	SUPPL	12	AP	2015-01-13	STANDARD
LABELING; Labeling	SUPPL	13	AP	2017-08-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2015-11-09	STANDARD
EFFICACY; Efficacy	SUPPL	16	AP	2016-05-19	STANDARD
LABELING; Labeling	SUPPL	17	AP	2019-04-23	STANDARD
EFFICACY; Efficacy	SUPPL	21	AP	2021-12-13	STANDARD
EFFICACY; Efficacy	SUPPL	23	AP	2022-04-14	STANDARD

Submissions Property Types

ORIG	1	Null	31
SUPPL	4	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	6
SUPPL	14	Null	0
SUPPL	16	Null	15
SUPPL	17	Null	6
SUPPL	21	Null	7
SUPPL	23	Null	6

TE Codes

001	Prescription	AB2
002	Prescription	AB2
003	Prescription	AB2
004	Prescription	AB2
005	Prescription	AB2
006	Prescription	AB2
007	Prescription	AB2
008	Prescription	AB2
009	Prescription	AB2
010	Prescription	AB2
011	Prescription	AB2
012	Prescription	AB2

CDER Filings

ALVOGEN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21116
            [companyName] => ALVOGEN
            [docInserts] => ["",""]
            [products] => [{"drugName":"THYRO-TABS","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":"THYRO-TABS","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":"THYRO-TABS","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":"THYRO-TABS","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":"THYRO-TABS","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":"THYRO-TABS","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":"THYRO-TABS","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":"THYRO-TABS","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"},{"drugName":"THYRO-TABS","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":"No"},{"drugName":"THYRO-TABS","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":"THYRO-TABS","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":"THYRO-TABS","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"}]
            [labels] => [{"actionDate":"04\/23\/2019","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021116s017lbl.pdf\"}]","notes":""},{"actionDate":"08\/31\/2017","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021116s013lbl.pdf\"}]","notes":""},{"actionDate":"03\/10\/2006","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021116s006lbl.pdf\"}]","notes":""},{"actionDate":"10\/24\/2002","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/21116lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"THYRO-TABS","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":"THYRO-TABS","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":"THYRO-TABS","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":"THYRO-TABS","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":"THYRO-TABS","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":"THYRO-TABS","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":"THYRO-TABS","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":"THYRO-TABS","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"},{"actionDate":"THYRO-TABS","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":"THYRO-TABS","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":"THYRO-TABS","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":"THYRO-TABS","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"}]
            [supplements] => 
            [actionDate] => 2019-04-23
        )

)