Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021292
Company: PROVELL
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 |
|---|---|---|---|---|---|
| 04/27/2022 | SUPPL-10 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021292Orig1s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021292Orig1s010ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 04/27/2022 | SUPPL-10 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021292Orig1s010lbl.pdf | |
| 04/27/2022 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021292Orig1s010lbl.pdf | |
| 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 | No | AB2 | 021342 | CEDIPROF INC |
| LEVOLET | LEVOTHYROXINE SODIUM | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET;ORAL | Prescription | No | AB2 | 021137 | GENUS LIFESCIENCES |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET;ORAL | Prescription | No | AB2 | 212399 | ACCORD HLTHCARE |
| 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 |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET;ORAL | Prescription | No | AB2 | 211417 | MACLEODS PHARMS LTD |
| 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 |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET;ORAL | Prescription | No | AB2 | 207588 | WATSON LABS TEVA |
| 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 | No | AB2 | 021342 | CEDIPROF INC |
| LEVOLET | LEVOTHYROXINE SODIUM | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET;ORAL | Prescription | No | AB2 | 021137 | GENUS LIFESCIENCES |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET;ORAL | Prescription | No | AB2 | 212399 | ACCORD HLTHCARE |
| 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 |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET;ORAL | Prescription | No | AB2 | 211417 | MACLEODS PHARMS LTD |
| 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 |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET;ORAL | Prescription | No | AB2 | 207588 | WATSON LABS TEVA |
| 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 | No | AB2 | 021342 | CEDIPROF INC |
| LEVOLET | LEVOTHYROXINE SODIUM | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET;ORAL | Prescription | No | AB2 | 021137 | GENUS LIFESCIENCES |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET;ORAL | Prescription | No | AB2 | 212399 | ACCORD HLTHCARE |
| 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 |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET;ORAL | Prescription | No | AB2 | 211417 | MACLEODS PHARMS LTD |
| 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 |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET;ORAL | Prescription | No | AB2 | 207588 | WATSON LABS TEVA |
| 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 | No | AB2 | 021342 | CEDIPROF INC |
| LEVOLET | LEVOTHYROXINE SODIUM | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET;ORAL | Prescription | No | AB2 | 021137 | GENUS LIFESCIENCES |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET;ORAL | Prescription | No | AB2 | 212399 | ACCORD HLTHCARE |
| 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 |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET;ORAL | Prescription | No | AB2 | 211417 | MACLEODS PHARMS LTD |
| 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 |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET;ORAL | Prescription | No | AB2 | 207588 | WATSON LABS TEVA |
| 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 | No | AB2 | 021342 | CEDIPROF INC |
| LEVOLET | LEVOTHYROXINE SODIUM | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET;ORAL | Prescription | No | AB2 | 021137 | GENUS LIFESCIENCES |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET;ORAL | Prescription | No | AB2 | 212399 | ACCORD HLTHCARE |
| 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 |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET;ORAL | Prescription | No | AB2 | 211417 | MACLEODS PHARMS LTD |
| 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 |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET;ORAL | Prescription | No | AB2 | 207588 | WATSON LABS TEVA |
| 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 | No | AB2 | 021342 | CEDIPROF INC |
| LEVOLET | LEVOTHYROXINE SODIUM | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET;ORAL | Prescription | No | AB2 | 021137 | GENUS LIFESCIENCES |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET;ORAL | Prescription | No | AB2 | 212399 | ACCORD HLTHCARE |
| 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 |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET;ORAL | Prescription | No | AB2 | 211417 | MACLEODS PHARMS LTD |
| 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 |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET;ORAL | Prescription | No | AB2 | 207588 | WATSON LABS TEVA |
| 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 | No | AB2 | 021342 | CEDIPROF INC |
| LEVOLET | LEVOTHYROXINE SODIUM | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET;ORAL | Prescription | No | AB2 | 021137 | GENUS LIFESCIENCES |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET;ORAL | Prescription | No | AB2 | 212399 | ACCORD HLTHCARE |
| 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 |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET;ORAL | Prescription | No | AB2 | 211417 | MACLEODS PHARMS LTD |
| 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 |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET;ORAL | Prescription | No | AB2 | 207588 | WATSON LABS TEVA |
| 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 | No | AB2 | 021342 | CEDIPROF INC |
| LEVOLET | LEVOTHYROXINE SODIUM | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET;ORAL | Prescription | No | AB2 | 021137 | GENUS LIFESCIENCES |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET;ORAL | Prescription | No | AB2 | 212399 | ACCORD HLTHCARE |
| 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 |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET;ORAL | Prescription | No | AB2 | 211417 | MACLEODS PHARMS LTD |
| 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 |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET;ORAL | Prescription | No | AB2 | 207588 | WATSON LABS TEVA |
| 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 | No | AB2 | 021342 | CEDIPROF INC |
| LEVOLET | LEVOTHYROXINE SODIUM | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET;ORAL | Prescription | No | AB2 | 021137 | GENUS LIFESCIENCES |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET;ORAL | Prescription | No | AB2 | 212399 | ACCORD HLTHCARE |
| 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 |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET;ORAL | Prescription | No | AB2 | 211417 | MACLEODS PHARMS LTD |
| 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 |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET;ORAL | Prescription | No | AB2 | 207588 | WATSON LABS TEVA |
| 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 | No | AB2 | 021342 | CEDIPROF INC |
| LEVOLET | LEVOTHYROXINE SODIUM | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET;ORAL | Prescription | No | AB2 | 021137 | GENUS LIFESCIENCES |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET;ORAL | Prescription | No | AB2 | 212399 | ACCORD HLTHCARE |
| 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 |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET;ORAL | Prescription | No | AB2 | 211417 | MACLEODS PHARMS LTD |
| 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 |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET;ORAL | Prescription | No | AB2 | 207588 | WATSON LABS TEVA |
| 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 | No | AB2 | 021342 | CEDIPROF INC |
| LEVOLET | LEVOTHYROXINE SODIUM | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET;ORAL | Prescription | No | AB2 | 021137 | GENUS LIFESCIENCES |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET;ORAL | Prescription | No | AB2 | 212399 | ACCORD HLTHCARE |
| 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 |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET;ORAL | Prescription | No | AB2 | 211417 | MACLEODS PHARMS LTD |
| 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 |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET;ORAL | Prescription | No | AB2 | 207588 | WATSON LABS TEVA |
| 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 |