Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211369
Company: TEVA PHARMS USA INC
Company: TEVA PHARMS USA INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.075MG | CAPSULE;ORAL | Discontinued | None | No | No |
LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.15MG | CAPSULE;ORAL | Discontinued | None | No | No |
LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.112MG | CAPSULE;ORAL | Discontinued | None | No | No |
LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.2MG | CAPSULE;ORAL | Prescription | AB | No | No |
LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.137MG | CAPSULE;ORAL | Prescription | AB | No | No |
LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.175MG | CAPSULE;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
10/28/2020 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211369Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/02/2023 | SUPPL-5 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
LEVOTHYROXINE SODIUM
CAPSULE;ORAL; 0.2MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.2MG | CAPSULE;ORAL | Prescription | No | AB | 211369 | TEVA PHARMS USA INC |
TIROSINT | LEVOTHYROXINE SODIUM | 0.2MG | CAPSULE;ORAL | Prescription | Yes | AB | 021924 | INSTITUT BIOCHIMIQUE |
CAPSULE;ORAL; 0.137MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.137MG | CAPSULE;ORAL | Prescription | No | AB | 211369 | TEVA PHARMS USA INC |
TIROSINT | LEVOTHYROXINE SODIUM | 0.137MG | CAPSULE;ORAL | Prescription | Yes | AB | 021924 | INSTITUT BIOCHIMIQUE |
CAPSULE;ORAL; 0.175MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.175MG | CAPSULE;ORAL | Prescription | No | AB | 211369 | TEVA PHARMS USA INC |
TIROSINT | LEVOTHYROXINE SODIUM | 0.175MG | CAPSULE;ORAL | Prescription | Yes | AB | 021924 | INSTITUT BIOCHIMIQUE |