Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021402
Company: ABBVIE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SYNTHROID LEVOTHYROXINE SODIUM 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB1,AB2 Yes No
SYNTHROID LEVOTHYROXINE SODIUM 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB1,AB2 Yes No
SYNTHROID LEVOTHYROXINE SODIUM 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB1,AB2 Yes No
SYNTHROID LEVOTHYROXINE SODIUM 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB1,AB2 Yes No
SYNTHROID LEVOTHYROXINE SODIUM 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB1,AB2 Yes No
SYNTHROID LEVOTHYROXINE SODIUM 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB1,AB2 Yes No
SYNTHROID LEVOTHYROXINE SODIUM 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB1,AB2 Yes No
SYNTHROID LEVOTHYROXINE SODIUM 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB1,AB2 Yes No
SYNTHROID LEVOTHYROXINE SODIUM 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB1,AB2 Yes No
SYNTHROID LEVOTHYROXINE SODIUM 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB1,AB2 Yes No
SYNTHROID LEVOTHYROXINE SODIUM 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB1,AB2 Yes Yes
SYNTHROID LEVOTHYROXINE SODIUM 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB1,AB2 Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/24/2002 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21402lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21402ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-402_Synthroid.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/13/2016 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

11/25/2015 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

02/23/2017 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021402s024s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021402Orig1s024,s028ltr.pdf
04/15/2015 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

04/08/2014 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

05/27/2014 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

02/23/2017 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021402s024s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021402Orig1s024,s028ltr.pdf
01/14/2011 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021402s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021402s020ltr.pdf
07/14/2008 SUPPL-17 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021402s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021402s017ltr.pdf
04/20/2008 SUPPL-11 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021402s011lbl.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/23/2017 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021402s024s028lbl.pdf
02/23/2017 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021402s024s028lbl.pdf
01/14/2011 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021402s020lbl.pdf
07/14/2008 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021402s017lbl.pdf
04/20/2008 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021402s011lbl.pdf
07/24/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21402lbl.pdf

SYNTHROID

TABLET;ORAL; 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVO-T LEVOTHYROXINE SODIUM 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB1 021342 CEDIPROF INC
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB1 076187 MYLAN
LEVOXYL LEVOTHYROXINE SODIUM 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB1 021301 KING PHARMS
SYNTHROID LEVOTHYROXINE SODIUM 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB1 021402 ABBVIE
UNITHROID LEVOTHYROXINE SODIUM 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB1 021210 STEVENS J

TABLET;ORAL; 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EUTHYROX LEVOTHYROXINE SODIUM 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB2 021292 PROVELL
LEVO-T LEVOTHYROXINE SODIUM 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB2 021342 CEDIPROF INC
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB2 209713 LUPIN ATLANTIS
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB2 076187 MYLAN
SYNTHROID LEVOTHYROXINE SODIUM 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB2 021402 ABBVIE
THYRO-TABS LEVOTHYROXINE SODIUM 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB2 021116 ALVOGEN
UNITHROID LEVOTHYROXINE SODIUM 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB2 021210 STEVENS J

TABLET;ORAL; 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVO-T LEVOTHYROXINE SODIUM 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB1 021342 CEDIPROF INC
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB1 076187 MYLAN
LEVOXYL LEVOTHYROXINE SODIUM 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB1 021301 KING PHARMS
SYNTHROID LEVOTHYROXINE SODIUM 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB1 021402 ABBVIE
UNITHROID LEVOTHYROXINE SODIUM 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB1 021210 STEVENS J

TABLET;ORAL; 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EUTHYROX LEVOTHYROXINE SODIUM 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB2 021292 PROVELL
LEVO-T LEVOTHYROXINE SODIUM 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB2 021342 CEDIPROF INC
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB2 209713 LUPIN ATLANTIS
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB2 076187 MYLAN
SYNTHROID LEVOTHYROXINE SODIUM 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB2 021402 ABBVIE
THYRO-TABS LEVOTHYROXINE SODIUM 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB2 021116 ALVOGEN
UNITHROID LEVOTHYROXINE SODIUM 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB2 021210 STEVENS J

TABLET;ORAL; 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVO-T LEVOTHYROXINE SODIUM 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB1 021342 CEDIPROF INC
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB1 076187 MYLAN
LEVOXYL LEVOTHYROXINE SODIUM 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB1 021301 KING PHARMS
SYNTHROID LEVOTHYROXINE SODIUM 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB1 021402 ABBVIE
UNITHROID LEVOTHYROXINE SODIUM 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB1 021210 STEVENS J

TABLET;ORAL; 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EUTHYROX LEVOTHYROXINE SODIUM 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB2 021292 PROVELL
LEVO-T LEVOTHYROXINE SODIUM 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB2 021342 CEDIPROF INC
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB2 209713 LUPIN ATLANTIS
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB2 076187 MYLAN
SYNTHROID LEVOTHYROXINE SODIUM 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB2 021402 ABBVIE
THYRO-TABS LEVOTHYROXINE SODIUM 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB2 021116 ALVOGEN
UNITHROID LEVOTHYROXINE SODIUM 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB2 021210 STEVENS J

TABLET;ORAL; 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVO-T LEVOTHYROXINE SODIUM 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB1 021342 CEDIPROF INC
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB1 076187 MYLAN
LEVOXYL LEVOTHYROXINE SODIUM 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB1 021301 KING PHARMS
SYNTHROID LEVOTHYROXINE SODIUM 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB1 021402 ABBVIE
UNITHROID LEVOTHYROXINE SODIUM 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB1 021210 STEVENS J

TABLET;ORAL; 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EUTHYROX LEVOTHYROXINE SODIUM 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB2 021292 PROVELL
LEVO-T LEVOTHYROXINE SODIUM 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB2 021342 CEDIPROF INC
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB2 209713 LUPIN ATLANTIS
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB2 076187 MYLAN
SYNTHROID LEVOTHYROXINE SODIUM 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB2 021402 ABBVIE
THYRO-TABS LEVOTHYROXINE SODIUM 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB2 021116 ALVOGEN
UNITHROID LEVOTHYROXINE SODIUM 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB2 021210 STEVENS J

TABLET;ORAL; 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVO-T LEVOTHYROXINE SODIUM 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB1 021342 CEDIPROF INC
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB1 076187 MYLAN
LEVOXYL LEVOTHYROXINE SODIUM 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB1 021301 KING PHARMS
SYNTHROID LEVOTHYROXINE SODIUM 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB1 021402 ABBVIE
UNITHROID LEVOTHYROXINE SODIUM 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB1 021210 STEVENS J

TABLET;ORAL; 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EUTHYROX LEVOTHYROXINE SODIUM 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB2 021292 PROVELL
LEVO-T LEVOTHYROXINE SODIUM 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB2 021342 CEDIPROF INC
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB2 209713 LUPIN ATLANTIS
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB2 076187 MYLAN
SYNTHROID LEVOTHYROXINE SODIUM 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB2 021402 ABBVIE
THYRO-TABS LEVOTHYROXINE SODIUM 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB2 021116 ALVOGEN
UNITHROID LEVOTHYROXINE SODIUM 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB2 021210 STEVENS J

TABLET;ORAL; 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVO-T LEVOTHYROXINE SODIUM 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB1 021342 CEDIPROF INC
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB1 076187 MYLAN
LEVOXYL LEVOTHYROXINE SODIUM 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB1 021301 KING PHARMS
SYNTHROID LEVOTHYROXINE SODIUM 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB1 021402 ABBVIE
UNITHROID LEVOTHYROXINE SODIUM 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB1 021210 STEVENS J

TABLET;ORAL; 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EUTHYROX LEVOTHYROXINE SODIUM 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB2 021292 PROVELL
LEVO-T LEVOTHYROXINE SODIUM 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB2 021342 CEDIPROF INC
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB2 209713 LUPIN ATLANTIS
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB2 076187 MYLAN
SYNTHROID LEVOTHYROXINE SODIUM 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB2 021402 ABBVIE
THYRO-TABS LEVOTHYROXINE SODIUM 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB2 021116 ALVOGEN
UNITHROID LEVOTHYROXINE SODIUM 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB2 021210 STEVENS J

TABLET;ORAL; 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVO-T LEVOTHYROXINE SODIUM 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB1 021342 CEDIPROF INC
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB1 076187 MYLAN
LEVOXYL LEVOTHYROXINE SODIUM 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB1 021301 KING PHARMS
SYNTHROID LEVOTHYROXINE SODIUM 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB1 021402 ABBVIE
UNITHROID LEVOTHYROXINE SODIUM 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB1 021210 STEVENS J

TABLET;ORAL; 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EUTHYROX LEVOTHYROXINE SODIUM 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB2 021292 PROVELL
LEVO-T LEVOTHYROXINE SODIUM 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB2 021342 CEDIPROF INC
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB2 209713 LUPIN ATLANTIS
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB2 076187 MYLAN
SYNTHROID LEVOTHYROXINE SODIUM 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB2 021402 ABBVIE
THYRO-TABS LEVOTHYROXINE SODIUM 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB2 021116 ALVOGEN
UNITHROID LEVOTHYROXINE SODIUM 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB2 021210 STEVENS J

TABLET;ORAL; 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVO-T LEVOTHYROXINE SODIUM 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB1 021342 CEDIPROF INC
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB1 076187 MYLAN
LEVOXYL LEVOTHYROXINE SODIUM 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB1 021301 KING PHARMS
SYNTHROID LEVOTHYROXINE SODIUM 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB1 021402 ABBVIE
UNITHROID LEVOTHYROXINE SODIUM 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB1 021210 STEVENS J

TABLET;ORAL; 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EUTHYROX LEVOTHYROXINE SODIUM 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB2 021292 PROVELL
LEVO-T LEVOTHYROXINE SODIUM 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB2 021342 CEDIPROF INC
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB2 209713 LUPIN ATLANTIS
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB2 076187 MYLAN
SYNTHROID LEVOTHYROXINE SODIUM 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB2 021402 ABBVIE
THYRO-TABS LEVOTHYROXINE SODIUM 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB2 021116 ALVOGEN
UNITHROID LEVOTHYROXINE SODIUM 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB2 021210 STEVENS J

TABLET;ORAL; 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVO-T LEVOTHYROXINE SODIUM 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB1 021342 CEDIPROF INC
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB1 076187 MYLAN
LEVOXYL LEVOTHYROXINE SODIUM 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB1 021301 KING PHARMS
SYNTHROID LEVOTHYROXINE SODIUM 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB1 021402 ABBVIE
UNITHROID LEVOTHYROXINE SODIUM 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB1 021210 STEVENS J

TABLET;ORAL; 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EUTHYROX LEVOTHYROXINE SODIUM 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB2 021292 PROVELL
LEVO-T LEVOTHYROXINE SODIUM 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB2 021342 CEDIPROF INC
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB2 209713 LUPIN ATLANTIS
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB2 076187 MYLAN
SYNTHROID LEVOTHYROXINE SODIUM 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB2 021402 ABBVIE
THYRO-TABS LEVOTHYROXINE SODIUM 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB2 021116 ALVOGEN
UNITHROID LEVOTHYROXINE SODIUM 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB2 021210 STEVENS J

TABLET;ORAL; 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVO-T LEVOTHYROXINE SODIUM 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB1 021342 CEDIPROF INC
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB1 076187 MYLAN
LEVOXYL LEVOTHYROXINE SODIUM 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB1 021301 KING PHARMS
SYNTHROID LEVOTHYROXINE SODIUM 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB1 021402 ABBVIE
UNITHROID LEVOTHYROXINE SODIUM 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB1 021210 STEVENS J

TABLET;ORAL; 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EUTHYROX LEVOTHYROXINE SODIUM 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB2 021292 PROVELL
LEVO-T LEVOTHYROXINE SODIUM 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB2 021342 CEDIPROF INC
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB2 209713 LUPIN ATLANTIS
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB2 076187 MYLAN
SYNTHROID LEVOTHYROXINE SODIUM 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB2 021402 ABBVIE
THYRO-TABS LEVOTHYROXINE SODIUM 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB2 021116 ALVOGEN
UNITHROID LEVOTHYROXINE SODIUM 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB2 021210 STEVENS J

TABLET;ORAL; 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVO-T LEVOTHYROXINE SODIUM 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB1 021342 CEDIPROF INC
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB1 076187 MYLAN
SYNTHROID LEVOTHYROXINE SODIUM 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB1 021402 ABBVIE
UNITHROID LEVOTHYROXINE SODIUM 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB1 021210 STEVENS J

TABLET;ORAL; 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVO-T LEVOTHYROXINE SODIUM 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB2 021342 CEDIPROF INC
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB2 209713 LUPIN ATLANTIS
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB2 076187 MYLAN
SYNTHROID LEVOTHYROXINE SODIUM 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB2 021402 ABBVIE
THYRO-TABS LEVOTHYROXINE SODIUM 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB2 021116 ALVOGEN
UNITHROID LEVOTHYROXINE SODIUM 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB2 021210 STEVENS J

TABLET;ORAL; 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVO-T LEVOTHYROXINE SODIUM 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB1 021342 CEDIPROF INC
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB1 076187 MYLAN
LEVOXYL LEVOTHYROXINE SODIUM 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB1 021301 KING PHARMS
SYNTHROID LEVOTHYROXINE SODIUM 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB1 021402 ABBVIE
UNITHROID LEVOTHYROXINE SODIUM 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB1 021210 STEVENS J

TABLET;ORAL; 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EUTHYROX LEVOTHYROXINE SODIUM 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB2 021292 PROVELL
LEVO-T LEVOTHYROXINE SODIUM 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB2 021342 CEDIPROF INC
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB2 209713 LUPIN ATLANTIS
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB2 076187 MYLAN
SYNTHROID LEVOTHYROXINE SODIUM 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB2 021402 ABBVIE
THYRO-TABS LEVOTHYROXINE SODIUM 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB2 021116 ALVOGEN
UNITHROID LEVOTHYROXINE SODIUM 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB2 021210 STEVENS J

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