Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075237
Company: MYLAN
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/2000/75-237_Sotalol%20Hydrochloride_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75237ta.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75237ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-237_Sotalol.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/01/2015 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

09/01/2015 SUPPL-6 Labeling

Label is not available on this site.

10/31/2002 SUPPL-3 Labeling

Label is not available on this site.

06/24/2002 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

10/13/2000 SUPPL-1 Labeling

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/2000/75-237_Sotalol%20Hydrochloride_prntlbl.pdf

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