Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075725
Company: RISING
Company: RISING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 80MG | TABLET;ORAL | Discontinued | None | No | No |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 120MG | TABLET;ORAL | Discontinued | None | No | No |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 160MG | TABLET;ORAL | Discontinued | None | No | No |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 240MG | 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 |
|---|---|---|---|---|---|---|---|
| 12/19/2000 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75725ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-725_Sotalol%20Hydrochloride.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/16/2021 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/22/2007 | SUPPL-4 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 06/04/2003 | SUPPL-1 | Labeling |
Label is not available on this site. |