Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075238
Company: WATSON LABS
Company: WATSON LABS
| 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 |
|---|---|---|---|---|---|---|---|
| 07/13/2000 | ORIG-1 | Approval |
Letter (PDF)
Letter (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75238ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75238ta.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/31/2003 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 11/07/2002 | SUPPL-7 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 09/16/2002 | SUPPL-6 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 06/24/2002 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 06/24/2002 | SUPPL-4 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/05/2000 | SUPPL-1 | Labeling |
Label is not available on this site. |