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BetapaceDrug - Betapace The trade name of the product as shown on the labeling.
Dosage -
TABLET; ORAL
Active Ingredient(s) -
Sotalol Hydrochloride
Strength -
320MG
Applicant -
BERLEX
New Drug Application (NDA) Number -
019865
Product Number -
004
Therapeutic Equivalence (TE) Code -
Approval Date -
Oct 30, 1992
Reference Listed Drug (RLD) -
No
Type -
DISCN
Applicant Full Name -
Berlex Inc
Betapace
Zorbtive 6mg/vial Injectable; Injection
Zorbtive 8.8mg/vial Injectable; Injection Serostim Lq 6mg/0.5ml Injectable; Subcutaneous Sorbitol 3% In Plastic Container 3gm/100ml Solution; Irrigation Sorbitol 3% In Plastic Container 3gm/100ml Solution; Irrigation Sorbitol 3.3% In Plastic Container 3.3gm/100ml Solution; Irrigation Betapace 120mg Tablet; Oral Betapace 160mg Tablet; Oral Betapace 240mg Tablet; Oral Betapace 320mg Tablet; Oral NewDrugInformation |