Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076764
Company: MYLAN
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.025MG | TABLET; ORAL | Discontinued | None | No | No |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.050MG | TABLET; ORAL | Discontinued | None | No | No |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.075MG | TABLET; ORAL | Discontinued | None | No | No |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.088MG | TABLET; ORAL | Discontinued | None | No | No |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.1MG | TABLET; ORAL | Discontinued | None | No | No |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.112MG | TABLET; ORAL | Discontinued | None | No | No |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.125MG | TABLET; ORAL | Discontinued | None | No | No |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.15MG | TABLET; ORAL | Discontinued | None | No | No |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.175MG | TABLET; ORAL | Discontinued | None | No | No |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.2MG | TABLET; ORAL | Discontinued | None | No | No |
| LEVOTHYROXINE SODIUM | 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 |
|---|---|---|---|---|---|---|---|
| 06/23/2004 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76764ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/76187ABrating.pdf |