Orange Book product · Brand (NDA)
BETAPACE
SOTALOL HYDROCHLORIDE
At a glance
Oct 30, 1992
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 30, 1992
34 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
SOTALOL HYDROCHLORIDE
Strength
80MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 019865
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2014SOTYLIZEBrand (NDA)
NDA 205108 · AZURITY
- 2009SOTALOL HYDROCHLORIDEBrand (NDA)
NDA 022306 · ALTATHERA PHARMS LLC
- 2003BETAPACE AFBrand (NDA)
NDA 021151 · LEGACY PHARMA
- 2018SOTALOL HYDROCHLORIDEGeneric (ANDA)
ANDA 207429 · REGCON HOLDINGS
- 2016SOTALOL HYDROCHLORIDEGeneric (ANDA)
ANDA 207428 · REGCON HOLDINGS
- 2007SOTALOL HYDROCHLORIDEGeneric (ANDA)
ANDA 077616 · AUROBINDO PHARMA USA
- 2005SOTALOL HYDROCHLORIDEGeneric (ANDA)
ANDA 077070 · EPIC PHARMA LLC
- 2004SOTALOL HYDROCHLORIDEGeneric (ANDA)
ANDA 076883 · TEVA
- 2004SOTALOL HYDROCHLORIDEGeneric (ANDA)
ANDA 076576 · SUN PHARM INDUSTRIES
- 2003SOTALOL HYDROCHLORIDEGeneric (ANDA)
ANDA 075563 · OXFORD PHARMS
- 2003SOTALOL HYDROCHLORIDEGeneric (ANDA)
ANDA 076214 · APOTEX
- 2002SOTALOL HYDROCHLORIDEGeneric (ANDA)
ANDA 076140 · APOTEX
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
