Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 021292
Company: PROVELL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EUTHYROX LEVOTHYROXINE SODIUM 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB2 No No
EUTHYROX LEVOTHYROXINE SODIUM 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB2 No No
EUTHYROX LEVOTHYROXINE SODIUM 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB2 No No
EUTHYROX LEVOTHYROXINE SODIUM 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB2 No No
EUTHYROX LEVOTHYROXINE SODIUM 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB2 No No
EUTHYROX LEVOTHYROXINE SODIUM 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB2 No No
EUTHYROX LEVOTHYROXINE SODIUM 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB2 No No
EUTHYROX LEVOTHYROXINE SODIUM 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB2 No No
EUTHYROX LEVOTHYROXINE SODIUM 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB2 No No
EUTHYROX LEVOTHYROXINE SODIUM 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB2 No No
EUTHYROX LEVOTHYROXINE SODIUM 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB2 No No
EUTHYROX LEVOTHYROXINE SODIUM 0.3MG TABLET;ORAL Discontinued None No 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
05/31/2002 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21292lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21292ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-292_Novothyrox.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/14/2018 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021292s004,021292s005,021292s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021292Orig1s004,021292Orig1s005,021292Orig1s006ltr.pdf
09/14/2018 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021292s004,021292s005,021292s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021292Orig1s004,021292Orig1s005,021292Orig1s006ltr.pdf
09/14/2018 SUPPL-4 Efficacy-Accelerated Approval Confirmatory Study Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021292s004,021292s005,021292s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021292Orig1s004,021292Orig1s005,021292Orig1s006ltr.pdf
03/26/2009 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021292s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021292s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/14/2018 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021292s004,021292s005,021292s006lbl.pdf
09/14/2018 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021292s004,021292s005,021292s006lbl.pdf
09/14/2018 SUPPL-4 Efficacy-Accelerated Approval Confirmatory Study Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021292s004,021292s005,021292s006lbl.pdf
03/26/2009 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021292s002lbl.pdf
05/31/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21292lbl.pdf

EUTHYROX

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 = 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 = 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 = 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 = 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 = 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 = 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 = 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 = 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 = 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; 0.2MG **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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English