NDA 021342

CEDIPROF INC

FDA Drug Application

Application #021342

Documents

• Letter: 2003-12-11
• Letter: 2003-08-28
• Letter: 2004-06-24
• Letter: 2004-06-24
• Label: 2002-03-01
• Label: 2008-06-12
• Label: 2009-06-22
• Review: 2002-06-19
• Letter: 2002-03-01
• Letter: 2008-06-13
• Letter: 2008-06-13
• Letter: 2009-06-17
• Letter: 2011-03-11
• Label: 2003-12-11
• Label: 2003-08-28
• Label: 2008-06-12
• Review: 2005-05-13
• Review: 2005-05-13
• Letter: 2017-12-07
• Label: 2017-12-07
• Review: 2002-06-19

Application Sponsors

NDA 021342

CEDIPROF INC

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	0	LEVO-T	LEVOTHYROXINE SODIUM
002	TABLET;ORAL	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	0	LEVO-T	LEVOTHYROXINE SODIUM
003	TABLET;ORAL	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	0	LEVO-T	LEVOTHYROXINE SODIUM
004	TABLET;ORAL	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	0	LEVO-T	LEVOTHYROXINE SODIUM
005	TABLET;ORAL	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	0	LEVO-T	LEVOTHYROXINE SODIUM
006	TABLET;ORAL	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	0	LEVO-T	LEVOTHYROXINE SODIUM
007	TABLET;ORAL	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	0	LEVO-T	LEVOTHYROXINE SODIUM
008	TABLET;ORAL	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	0	LEVO-T	LEVOTHYROXINE SODIUM
009	TABLET;ORAL	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	0	LEVO-T	LEVOTHYROXINE SODIUM
010	TABLET;ORAL	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	0	LEVO-T	LEVOTHYROXINE SODIUM
011	TABLET;ORAL	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	0	LEVO-T	LEVOTHYROXINE SODIUM
012	TABLET;ORAL	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	0	LEVO-T	LEVOTHYROXINE SODIUM

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2002-03-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2003-08-21	STANDARD
EFFICACY; Efficacy	SUPPL	3	AP	2004-06-23	UNKNOWN
EFFICACY; Efficacy	SUPPL	4	AP	2004-06-23	STANDARD
LABELING; Labeling	SUPPL	8	AP	2008-06-10	STANDARD
LABELING; Labeling	SUPPL	14	AP	2008-06-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2009-06-14	STANDARD
EFFICACY; Efficacy	SUPPL	20	AP	2011-03-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2012-11-20	STANDARD
LABELING; Labeling	SUPPL	23	AP	2017-12-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	2015-02-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	2017-01-12	STANDARD

Submissions Property Types

ORIG	1	Null	31
SUPPL	2	Null	0
SUPPL	16	Null	0
SUPPL	20	Null	6
SUPPL	22	Null	0
SUPPL	23	Null	15
SUPPL	24	Null	0

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

CEDIPROF INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21342
            [companyName] => CEDIPROF INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVO-T","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":"No","rs":"No"},{"drugName":"LEVO-T","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":"No","rs":"No"},{"drugName":"LEVO-T","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":"No","rs":"No"},{"drugName":"LEVO-T","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":"No","rs":"No"},{"drugName":"LEVO-T","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":"No","rs":"No"},{"drugName":"LEVO-T","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":"No","rs":"No"},{"drugName":"LEVO-T","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":"No","rs":"No"},{"drugName":"LEVO-T","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":"No","rs":"No"},{"drugName":"LEVO-T","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":"No","rs":"No"},{"drugName":"LEVO-T","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":"No","rs":"No"},{"drugName":"LEVO-T","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":"No","rs":"No"},{"drugName":"LEVO-T","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":"No","rs":"No"}]
            [labels] => [{"actionDate":"12\/05\/2017","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021342s023lbl.pdf\"}]","notes":""},{"actionDate":"06\/14\/2009","submission":"SUPPL-16","supplementCategories":"Manufacturing (CMC)-Control","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021342s016lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"06\/10\/2008","submission":"SUPPL-14","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021342s008s014lbl.pdf\"}]","notes":""},{"actionDate":"06\/10\/2008","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021342s008s014lbl.pdf\"}]","notes":""},{"actionDate":"12\/08\/2003","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)-Control","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/21342scs001_Levo-T_lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"08\/21\/2003","submission":"SUPPL-2","supplementCategories":"Manufacturing (CMC)-Control","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/21342scs002_levoT_lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"03\/01\/2002","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/21342lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"LEVO-T","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":">No"},{"actionDate":"LEVO-T","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":">No"},{"actionDate":"LEVO-T","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":">No"},{"actionDate":"LEVO-T","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":">No"},{"actionDate":"LEVO-T","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":">No"},{"actionDate":"LEVO-T","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":">No"},{"actionDate":"LEVO-T","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":">No"},{"actionDate":"LEVO-T","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":">No"},{"actionDate":"LEVO-T","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":">No"},{"actionDate":"LEVO-T","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":">No"},{"actionDate":"LEVO-T","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":">No"},{"actionDate":"LEVO-T","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":">No"}]
            [supplements] => 
            [actionDate] => 2017-12-05
        )

)