FDA Approval Activities for this Drug…

Betapace (sotalol hydrochloride) Tablets, 80, 120, 160, & 240 mg, Berlex NDA 19-865/S10 10/1/01 6/19/02 6/19/02 6/19/02 Betapace (sotalol hydrochloride) Tablets, Berlex NDA 21-151/S5 4/2/03 4/18/03 Betapace (sotalol hydrochloride) Tablets, Berlex NDA 21-151/S4 3/14/03 3/26/03 Betapace (sotalol hydrochloride) Tablets, Berlex NDA 21-151 2/22/00 2/24/00 2/24/00 Betapace Indication: Maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (AFIB/AFL) in patients with symptomatic AFIB/AFL who are currently in sinus rhythm. Because Betapace can cause life-threatening ventricular arrhythmias, it should be reserved for patients in whom AFIB/AFL is highly symptomatic. Patients with paroxysmal AFIB/AFL that is easily reversed should usually not be given Betapace . Sorine (Sotalol Hydrochloride Tablets), 80 mg, 120 mg, 160 mg, and 240 mg. Upsher-Smith , ANDA 75-500 4/27/01 6/5/01 Sotalol Hydrochloride Tablets (AF), 80, 120, & 160mg, Torpharm ANDA 76-214 8/27/03 Sotalol Hydrochloride Tablets, 80, 120, & 160mg, Torpharm ANDA 76-214 3/5/03 Sotalol Hydrochloride Tablets, 80mg, 120mg, 160mg, & 240mg, Torpharm ANDA 76-140 9/26/02 Sotalol Hydrochloride Tablets, 80mg, 120mg, 160mg, & 240mg, Mylan ANDA 75-725 12/19/00 3/5/01 12/5/01 Sotalol Hydrochloride Tablets, 80mg, 120mg, 160mg, & 240mg, Impax, ANDA 75-663 11/7/00 11/16/00 Sotalol Hydrochloride Tablets, 80mg, 120mg, 160mg, & 240mg, Mutual Pharmaceutical Company ANDA 75-515 10/15/01 4/14/03 Sotalol Hydrochloride Tablets, 80mg, 120mg, 180mg, & 240mg, Upsher-Smith , ANDA 75-500 4/27/01 Sotalol Hydrochloride Tablets, 80mg, 120mg, 160mg, & 240mg, Teva ANDA 75-429 5/1/00 5/1/00 12/17/01 Sotalol Hydrochloride Tablets, 80mg, 120mg, 160mg, & 240mg (Tentatively Approved 7/20/99) Teva ANDA 75-429 7/20/99 7/29/99 Sotalol Hydrochloride Tablets, 80mg, 120mg, 160mg, & 240mg, Eon Labs Manufacturing, ANDA 75-366 5/1/00 5/22/00 12/18/01 Sotalol Hydrochloride Tablets, 80mg, 120mg, 160mg, & 240mg (Tentatively Approved 7/26/99) Eon Labs Manufacturing, ANDA 75-366 7/26/99 7/29/99 Sotalol Hydrochloride Tablets, 80 mg, 120 mg, 160 mg, & 240 mg., Watson, ANDA 75-238 7/13/00 10/31/00 Sotalol Hydrochloride Tablets, 80 mg, 120 mg, 160 mg, & 240 mg. Watson, ANDA 75-238 6/7/99 6/11/99 Sotalol Hydrochloride Tablets, 80 mg, 120 mg, 160 mg, & 240 mg., Genpharm ANDA 75-237 5/1/00 5/1/00 12/28/01 Sotalol Hydrochloride Tablets, 80 mg, 120 mg, 160 mg, & 240 mg. Par Pharmaceutical, ANDA 75-237 SOTALOL HYDROCHLORIDE Tablet; 120MG SOTALOL HCL Apotex 076140 AB1 SOTALOL HYDROCHLORIDE Tablet; 160MG SOTALOL HCL Apotex 076140 AB1 SOTALOL HYDROCHLORIDE Tablet; 240MG SOTALOL HCL Apotex 076140 AB1 SOTALOL HYDROCHLORIDE Tablet; 80MG SOTALOL HCL Apotex 021151 AB2 SOTALOL HYDROCHLORIDE Tablet; 120MG BETAPACE BERLEX 019865 AB1 SOTALOL HYDROCHLORIDE Tablet; 120MG BETAPACE BERLEX 019865 AB1 SOTALOL HYDROCHLORIDE Tablet; 160MG BETAPACE BERLEX 021151 AB2 SOTALOL HYDROCHLORIDE Tablet; 160MG BETAPACE BERLEX 019865 AB1 SOTALOL HYDROCHLORIDE Tablet; 240MG BETAPACE BERLEX 019865 AB1 SOTALOL HYDROCHLORIDE Tablet; 80MG BETAPACE BERLEX 021151 AB2 SOTALOL HYDROCHLORIDE Tablet; 80MG BETAPACE BERLEX 075366 AB1 SOTALOL HYDROCHLORIDE Tablet; 120MG SOTALOL HCL Eon 075366 AB1 SOTALOL HYDROCHLORIDE Tablet; 160MG SOTALOL HCL Eon 075366 AB1 SOTALOL HYDROCHLORIDE Tablet; 240MG SOTALOL HCL Eon 075366 AB1 SOTALOL HYDROCHLORIDE Tablet; 80MG SOTALOL HCL Eon 075237 AB1 SOTALOL HYDROCHLORIDE Tablet; 120MG SOTALOL HCL Genpharm 075237 AB1 SOTALOL HYDROCHLORIDE Tablet; 160MG SOTALOL HCL Genpharm 075237 AB1 SOTALOL HYDROCHLORIDE Tablet; 240MG SOTALOL HCL Genpharm 075237 AB1 SOTALOL HYDROCHLORIDE Tablet; 80MG SOTALOL HCL Genpharm 075663 AB1 SOTALOL HYDROCHLORIDE Tablet; 120MG SOTALOL HCL Impax 075663 AB1 SOTALOL HYDROCHLORIDE Tablet; 160MG SOTALOL HCL Impax 075663 AB1 SOTALOL HYDROCHLORIDE Tablet; 240MG SOTALOL HCL Impax 075663 AB1 SOTALOL HYDROCHLORIDE Tablet; 80MG SOTALOL HCL Impax 075515 AB1 SOTALOL HYDROCHLORIDE Tablet; 120MG SOTALOL HCL Mutual 075515 AB1 SOTALOL HYDROCHLORIDE Tablet; 160MG SOTALOL HCL Mutual 075515 AB1 SOTALOL HYDROCHLORIDE Tablet; 240MG SOTALOL HCL Mutual 075515 AB1 SOTALOL HYDROCHLORIDE Tablet; 80MG SOTALOL HCL Mutual 075725 AB1 SOTALOL HYDROCHLORIDE Tablet; 120MG SOTALOL HCL Mylan 075725 AB1 SOTALOL HYDROCHLORIDE Tablet; 160MG SOTALOL HCL Mylan 075725 AB1 SOTALOL HYDROCHLORIDE Tablet; 240MG SOTALOL HCL Mylan 075725 AB1 SOTALOL HYDROCHLORIDE Tablet; 80MG SOTALOL HCL Mylan 075429 AB1 SOTALOL HYDROCHLORIDE Tablet; 120MG SOTALOL HCL Teva 075429 AB1 SOTALOL HYDROCHLORIDE Tablet; 160MG SOTALOL HCL Teva 075429 AB1 SOTALOL HYDROCHLORIDE Tablet; 240MG SOTALOL HCL Teva 075429 AB1 SOTALOL HYDROCHLORIDE Tablet; 80MG SOTALOL HCL Teva 076214 AB2 SOTALOL HYDROCHLORIDE Tablet; 120MG SOTALOL HCL Torpharm 076214 AB2 SOTALOL HYDROCHLORIDE Tablet; 160MG SOTALOL HCL Torpharm 076214 AB2 SOTALOL HYDROCHLORIDE Tablet; 80MG SOTALOL HCL Torpharm 075500 AB1 SOTALOL HYDROCHLORIDE Tablet; 120MG SORINE Upsher Smith 075500 AB1 SOTALOL HYDROCHLORIDE Tablet; 160MG SORINE Upsher Smith 075500 AB1 SOTALOL HYDROCHLORIDE Tablet; 240MG SORINE Upsher Smith 075500 AB1 SOTALOL HYDROCHLORIDE Tablet; 80MG SORINE Upsher Smith 075238 AB1 SOTALOL HYDROCHLORIDE Tablet; 120MG SOTALOL HCL Watson 075238 AB1 SOTALOL HYDROCHLORIDE Tablet; 160MG SOTALOL HCL Watson 075238 AB1 SOTALOL HYDROCHLORIDE Tablet; 240MG SOTALOL HCL Watson 075238 AB1 SOTALOL HYDROCHLORIDE Tablet; 80MG SOTALOL HCL Watson Sotalol Hydrochloride Tablets, Vintage Sotalol Hydrochloride Tablets (AF), Mutual Pharmaceutical Sotalol Hydrochloride (AF) Tablet, Teva Pharmaceuticals, Approval

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