Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 207429
Company: BEXIMCO PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 80MG TABLET;ORAL Prescription AB2 No No
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 120MG TABLET;ORAL Prescription AB2 No No
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 160MG TABLET;ORAL Prescription AB2 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
11/02/2018 ORIG-1 Approval STANDARD

Label is not available on this site.

SOTALOL HYDROCHLORIDE

TABLET;ORAL; 80MG
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BETAPACE AF SOTALOL HYDROCHLORIDE 80MG TABLET;ORAL Prescription Yes AB2 021151 COVIS PHARMA BV
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 80MG TABLET;ORAL Prescription No AB2 076214 APOTEX
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 80MG TABLET;ORAL Prescription No AB2 207429 BEXIMCO PHARMS USA
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 80MG TABLET;ORAL Prescription No AB2 077070 EPIC PHARMA INC
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 80MG TABLET;ORAL Prescription No AB2 077616 MYLAN

TABLET;ORAL; 120MG
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BETAPACE AF SOTALOL HYDROCHLORIDE 120MG TABLET;ORAL Prescription Yes AB2 021151 COVIS PHARMA BV
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 120MG TABLET;ORAL Prescription No AB2 076214 APOTEX
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 120MG TABLET;ORAL Prescription No AB2 207429 BEXIMCO PHARMS USA
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 120MG TABLET;ORAL Prescription No AB2 077070 EPIC PHARMA INC
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 120MG TABLET;ORAL Prescription No AB2 077616 MYLAN

TABLET;ORAL; 160MG
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BETAPACE AF SOTALOL HYDROCHLORIDE 160MG TABLET;ORAL Prescription Yes AB2 021151 COVIS PHARMA BV
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 160MG TABLET;ORAL Prescription No AB2 076214 APOTEX
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 160MG TABLET;ORAL Prescription No AB2 207429 BEXIMCO PHARMS USA
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 160MG TABLET;ORAL Prescription No AB2 077070 EPIC PHARMA INC
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 160MG TABLET;ORAL Prescription No AB2 077616 MYLAN

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