Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210831
Company: AMNEAL
Company: AMNEAL
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 | 0.05MG | 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 | 0.137MG | 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 |
---|---|---|---|---|---|---|---|
02/19/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/29/2023 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
08/29/2023 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |