Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075238
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/1999/75238ta.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75238ltr.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.

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