Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075366
Company: UPSHER SMITH LABS
Company: UPSHER SMITH 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 |
---|---|---|---|---|---|---|---|
05/01/2000 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-366_Sotalol%20Hydrochloride_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75366ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75366ta.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-366_Sotalol.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/18/2015 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
12/18/2015 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
09/18/2002 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
04/30/2002 | SUPPL-4 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
10/25/2000 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
09/07/2000 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
09/07/2000 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/01/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-366_Sotalol%20Hydrochloride_prntlbl.pdf |