Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021924
Company: IBSA
Company: IBSA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TIROSINT | LEVOTHYROXINE SODIUM | 0.025MG | CAPSULE;ORAL | Prescription | None | Yes | No |
TIROSINT | LEVOTHYROXINE SODIUM | 0.05MG | CAPSULE;ORAL | Prescription | None | Yes | No |
TIROSINT | LEVOTHYROXINE SODIUM | 0.075MG | CAPSULE;ORAL | Prescription | None | Yes | No |
TIROSINT | LEVOTHYROXINE SODIUM | 0.1MG | CAPSULE;ORAL | Prescription | None | Yes | No |
TIROSINT | LEVOTHYROXINE SODIUM | 0.125MG | CAPSULE;ORAL | Prescription | None | Yes | No |
TIROSINT | LEVOTHYROXINE SODIUM | 0.15MG | CAPSULE;ORAL | Prescription | None | Yes | No |
TIROSINT | LEVOTHYROXINE SODIUM | 0.112MG | CAPSULE;ORAL | Prescription | None | Yes | No |
TIROSINT | LEVOTHYROXINE SODIUM | 0.137MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
TIROSINT | LEVOTHYROXINE SODIUM | 0.088MG | CAPSULE;ORAL | Prescription | None | Yes | No |
TIROSINT | LEVOTHYROXINE SODIUM | 0.175MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
TIROSINT | LEVOTHYROXINE SODIUM | 0.2MG | CAPSULE;ORAL | Prescription | AB | Yes | Yes |
TIROSINT | LEVOTHYROXINE SODIUM | 0.013MG | CAPSULE;ORAL | Prescription | None | Yes | No |
TIROSINT | LEVOTHYROXINE SODIUM | 0.0375MG | CAPSULE;ORAL | Prescription | None | Yes | No |
TIROSINT | LEVOTHYROXINE SODIUM | 0.044MG | CAPSULE;ORAL | Prescription | None | Yes | No |
TIROSINT | LEVOTHYROXINE SODIUM | 0.0625MG | CAPSULE;ORAL | Prescription | 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 |
---|---|---|---|---|---|---|---|
10/13/2006 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021924lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021924s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021924s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/22/2022 | SUPPL-21 | Manufacturing (CMC)-New Strength |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021924Orig1s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021924Orig1s021ltr.pdf | |
12/08/2017 | SUPPL-13 | Labeling-Container/Carton Labels |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021924s013lbl.pdf | |
04/25/2017 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
07/11/2013 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/04/2012 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021924s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021924s006ltr.pdf | |
12/17/2007 | SUPPL-2 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021924s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021924s002ltr.pdf | |
01/01/2008 | SUPPL-1 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
06/22/2022 | SUPPL-21 | Manufacturing (CMC)-New Strength | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021924Orig1s021lbl.pdf | |
12/08/2017 | SUPPL-13 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021924s013lbl.pdf | |
03/04/2012 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021924s006lbl.pdf | |
12/17/2007 | SUPPL-2 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021924s002lbl.pdf | |
10/13/2006 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021924lbl.pdf |
TIROSINT
CAPSULE;ORAL; 0.137MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TIROSINT | LEVOTHYROXINE SODIUM | 0.137MG | CAPSULE;ORAL | Prescription | Yes | AB | 021924 | IBSA |
CAPSULE;ORAL; 0.175MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TIROSINT | LEVOTHYROXINE SODIUM | 0.175MG | CAPSULE;ORAL | Prescription | Yes | AB | 021924 | IBSA |
CAPSULE;ORAL; 0.2MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TIROSINT | LEVOTHYROXINE SODIUM | 0.2MG | CAPSULE;ORAL | Prescription | Yes | AB | 021924 | IBSA |