Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021301
Company: KING PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVOXYL LEVOTHYROXINE SODIUM 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB1,AB3 Yes No
LEVOXYL LEVOTHYROXINE SODIUM 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB1,AB3 Yes No
LEVOXYL LEVOTHYROXINE SODIUM 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB1,AB3 Yes No
LEVOXYL LEVOTHYROXINE SODIUM 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB1,AB3 Yes No
LEVOXYL LEVOTHYROXINE SODIUM 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB1,AB3 Yes No
LEVOXYL LEVOTHYROXINE SODIUM 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB1,AB3 Yes No
LEVOXYL LEVOTHYROXINE SODIUM 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB1,AB3 Yes No
LEVOXYL LEVOTHYROXINE SODIUM 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB1,AB3 Yes No
LEVOXYL LEVOTHYROXINE SODIUM 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB1,AB3 Yes No
LEVOXYL LEVOTHYROXINE SODIUM 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB1,AB3 Yes No
LEVOXYL LEVOTHYROXINE SODIUM 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB1,AB3 Yes Yes
LEVOXYL LEVOTHYROXINE SODIUM 0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
05/25/2001 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21301lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21301ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-301_Levoxyl.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/20/2018 SUPPL-38 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021301s038lbl.pdf
11/05/2014 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

05/06/2014 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

12/14/2012 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

09/01/2009 SUPPL-28 Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021301_s028_levoxyl tablets.pdf
03/21/2011 SUPPL-27 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021301s027lbl.pdf
07/08/2008 SUPPL-26 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021301s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021301s026ltr.pdf
03/08/2005 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21301s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21301s014ltr.pdf
07/23/2003 SUPPL-6 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21301scm006ltr.pdf
12/31/2002 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

07/17/2002 SUPPL-2 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21301slr002ltr.pdf
04/03/2002 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/20/2018 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021301s038lbl.pdf
03/21/2011 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021301s027lbl.pdf
03/21/2011 SUPPL-27 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021301s027lbl.pdf
07/08/2008 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021301s026lbl.pdf
03/08/2005 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21301s014lbl.pdf
05/25/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21301lbl.pdf

LEVOXYL

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 = AB3

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 AB3 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 AB3 076187 MYLAN
LEVOXYL LEVOTHYROXINE SODIUM 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB3 021301 KING PHARMS
UNITHROID LEVOTHYROXINE SODIUM 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB3 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 = AB3

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 AB3 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 AB3 076187 MYLAN
LEVOXYL LEVOTHYROXINE SODIUM 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB3 021301 KING PHARMS
UNITHROID LEVOTHYROXINE SODIUM 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB3 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 = AB3

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 AB3 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 AB3 076187 MYLAN
LEVOXYL LEVOTHYROXINE SODIUM 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB3 021301 KING PHARMS
UNITHROID LEVOTHYROXINE SODIUM 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB3 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 = AB3

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 AB3 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 AB3 076187 MYLAN
LEVOXYL LEVOTHYROXINE SODIUM 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB3 021301 KING PHARMS
UNITHROID LEVOTHYROXINE SODIUM 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB3 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 = AB3

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 AB3 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 AB3 076187 MYLAN
LEVOXYL LEVOTHYROXINE SODIUM 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB3 021301 KING PHARMS
UNITHROID LEVOTHYROXINE SODIUM 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB3 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 = AB3

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 AB3 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 AB3 076187 MYLAN
LEVOXYL LEVOTHYROXINE SODIUM 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB3 021301 KING PHARMS
UNITHROID LEVOTHYROXINE SODIUM 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB3 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 = AB3

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 AB3 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 AB3 076187 MYLAN
LEVOXYL LEVOTHYROXINE SODIUM 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB3 021301 KING PHARMS
UNITHROID LEVOTHYROXINE SODIUM 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB3 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 = AB3

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 AB3 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 AB3 076187 MYLAN
LEVOXYL LEVOTHYROXINE SODIUM 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB3 021301 KING PHARMS
UNITHROID LEVOTHYROXINE SODIUM 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB3 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 = AB3

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 AB3 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 AB3 076187 MYLAN
LEVOXYL LEVOTHYROXINE SODIUM 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB3 021301 KING PHARMS
UNITHROID LEVOTHYROXINE SODIUM 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB3 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 = AB3

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 AB3 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 AB3 076187 MYLAN
LEVOXYL LEVOTHYROXINE SODIUM 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB3 021301 KING PHARMS
UNITHROID LEVOTHYROXINE SODIUM 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB3 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 = AB3

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 AB3 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 AB3 076187 MYLAN
LEVOXYL LEVOTHYROXINE SODIUM 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB3 021301 KING PHARMS
UNITHROID LEVOTHYROXINE SODIUM 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB3 021210 STEVENS J

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