Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075500
Company: UPSHER SMITH LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SORINE SOTALOL HYDROCHLORIDE 80MG TABLET;ORAL Prescription AB1 No No
SORINE SOTALOL HYDROCHLORIDE 160MG TABLET;ORAL Prescription AB1 No No
SORINE SOTALOL HYDROCHLORIDE 240MG TABLET;ORAL Prescription AB1 No No
SORINE SOTALOL HYDROCHLORIDE 120MG TABLET;ORAL Prescription AB1 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
04/27/2001 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75500ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/02/2015 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

03/02/2015 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

05/13/2003 SUPPL-2 Labeling

Label is not available on this site.

12/19/2002 SUPPL-1 Manufacturing (CMC)-Facility

Label is not available on this site.

SORINE

TABLET;ORAL; 80MG
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BETAPACE SOTALOL HYDROCHLORIDE 80MG TABLET;ORAL Prescription Yes AB1 019865 COVIS PHARMA BV
SORINE SOTALOL HYDROCHLORIDE 80MG TABLET;ORAL Prescription No AB1 075500 UPSHER SMITH LABS
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 80MG TABLET;ORAL Prescription No AB1 076140 APOTEX INC
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 80MG TABLET;ORAL Prescription No AB1 207428 BEXIMCO PHARMS USA
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 80MG TABLET;ORAL Prescription No AB1 075563 OXFORD PHARMS
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 80MG TABLET;ORAL Prescription No AB1 075429 TEVA
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 80MG TABLET;ORAL Prescription No AB1 075366 UPSHER SMITH LABS

TABLET;ORAL; 160MG
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BETAPACE SOTALOL HYDROCHLORIDE 160MG TABLET;ORAL Prescription Yes AB1 019865 COVIS PHARMA BV
SORINE SOTALOL HYDROCHLORIDE 160MG TABLET;ORAL Prescription No AB1 075500 UPSHER SMITH LABS
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 160MG TABLET;ORAL Prescription No AB1 076140 APOTEX INC
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 160MG TABLET;ORAL Prescription No AB1 207428 BEXIMCO PHARMS USA
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 160MG TABLET;ORAL Prescription No AB1 075563 OXFORD PHARMS
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 160MG TABLET;ORAL Prescription No AB1 075429 TEVA
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 160MG TABLET;ORAL Prescription No AB1 075366 UPSHER SMITH LABS

TABLET;ORAL; 240MG
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BETAPACE SOTALOL HYDROCHLORIDE 240MG TABLET;ORAL Prescription Yes AB1 019865 COVIS PHARMA BV
SORINE SOTALOL HYDROCHLORIDE 240MG TABLET;ORAL Prescription No AB1 075500 UPSHER SMITH LABS
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 240MG TABLET;ORAL Prescription No AB1 076140 APOTEX INC
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 240MG TABLET;ORAL Prescription No AB1 075563 OXFORD PHARMS
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 240MG TABLET;ORAL Prescription No AB1 075429 TEVA
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 240MG TABLET;ORAL Prescription No AB1 075366 UPSHER SMITH LABS

TABLET;ORAL; 120MG
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BETAPACE SOTALOL HYDROCHLORIDE 120MG TABLET;ORAL Prescription Yes AB1 019865 COVIS PHARMA BV
SORINE SOTALOL HYDROCHLORIDE 120MG TABLET;ORAL Prescription No AB1 075500 UPSHER SMITH LABS
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 120MG TABLET;ORAL Prescription No AB1 076140 APOTEX INC
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 120MG TABLET;ORAL Prescription No AB1 207428 BEXIMCO PHARMS USA
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 120MG TABLET;ORAL Prescription No AB1 075563 OXFORD PHARMS
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 120MG TABLET;ORAL Prescription No AB1 075429 TEVA
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 120MG TABLET;ORAL Prescription No AB1 075366 UPSHER SMITH LABS

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