Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213256
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 | 0.088MG | CAPSULE;ORAL | Discontinued | None | No | No |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.1MG | CAPSULE;ORAL | Discontinued | None | No | No |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.125MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 01/06/2021 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213256Orig1s000ltr.pdf |