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Betapace AfDrug - Betapace Af The trade name of the product as shown on the labeling.
Dosage -
TABLET; ORAL
Active Ingredient(s) -
Sotalol Hydrochloride
Strength -
100MG
Applicant -
BERLEX
New Drug Application (NDA) Number -
021151
Product Number -
005
Therapeutic Equivalence (TE) Code -
Approval Date -
Mar 14, 2003
Reference Listed Drug (RLD) -
No
Type -
DISCN
Applicant Full Name -
Berlex Inc
Betapace Af
Betapace 80mg Tablet; Oral
Betapace Af 100mg Tablet; Oral 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 |