FDA Approval Activities for this Drug…

BuSpar (Buspirone Hydrochloride) Tablets Bristol-Myers Squibb Co. NDA 18-731/S39 & S45 BuSpar (Buspirone Hydrochloride) Tablets Bristol-Myers Squibb Co. NDA 18-731/S46 2/7/02 4/17/02 BuSpar (Buspirone Hydrochloride) Tablets Bristol-Myers Squibb Co. NDA 18-731/S43 7/19/01 11/5/01 11/5/01 Buspirone Hydrochloride Tablets USP, 30 mg, Mylan Technologies ANDA 76-008 6/28/01 Buspirone Hydrochloride Tablets USP, 5 mg and 10 mg, Novopharm Limited ANDA 74-684 10/9/98 10/13/98 Buspirone Hydrochloride Tablets USP, 5 mg, 10 mg & 15 mg, Second 5/23/00 Novopharm Limited ANDA 74-684 5/23/00 5/31/00 Buspirone Hydrochloride Tablets USP,5 mg and 10 mg, 12/22/1998 & 9/17/99 ESI Lederle ANDA 75-011 12/22/98 9/17/99 12/22/98 9/24/99 Buspirone Hydrochloride Tablets USP,5 mg and 10 mg, Second 5/23/00 ESI Lederle ANDA 75-011 5/23/00 5/31/00 Buspirone Hydrochloride Tablets USP, 5 mg, 10 mg & 15 mg, Teva USA ANDA 75-022 2/28/02 Buspirone Hydrochloride Tablets USP, 5 mg, 10 mg & 15 mg, Teva USA ANDA 75-022 8/3/01 Buspirone Hydrochloride Tablets USP, 15 mg, Egis Ltd. ANDA 75-119/S1 & S2 1/23/03 Buspirone Hydrochloride Tablets USP, 5 mg and 10 mg, Egis Ltd. ANDA 75-119 3/14/02 4/9/03 Buspirone Hydrochloride Tablets USP, 5 mg and 10 mg, Aegis ANDA 75-119 7/27/00 10/31/00 Buspirone Hydrochloride Tablets USP, 5 mg and 10 mg, 11/16/1998 Aegis ANDA 75-119 11/16/98 11/16/98 Buspirone Hydrochloride Tablets, 5 mg and 10 mg Chelsea ANDA 75-195 4/30/98 5/8/98 Buspirone Hydrochloride Tablets USP, 15 mg, Watson, ANDA 74-253/S1 & S2 3/13/02 4/9/03 Buspirone Hydrochloride Tablets USP, 5 mg and 10 mg, ( 15 mg strengths remain ) Danbury Pharmacal, ANDA 74-253 3/28/01 3/30/01 Buspirone Hydrochloride Tablets USP, 5 & 10 mg, Mylan ANDA 75-272/S3 & S4 3/1/02 4/10/03 Buspirone Hydrochloride Tablets USP, 15 mg, ( 5 mg & 10 mg strengths remain ) Mylan ANDA 75-272 3/28/01 3/30/01 Buspirone Hydrochloride Tablets USP, 5 mg, 10 mg, and 15 mg, Mylan ANDA 75-272 8/2/00 10/30/00 Buspirone Hydrochloride Tablets USP, 5 mg, 10 mg, and 15 mg, 11/10/98 Mylan ANDA 75-272 11/10/98 11/16/98 Buspirone Hydrochloride Tablets USP, 5 mg, 10 and 15 mg, Zenith Goldline ANDA 75-385 3/1/02 4/10/03 Buspirone Hydrochloride Tablets USP, 5 mg, 10 mg, and 15 mg, PharmEx Products, ANDA 75-388 5/9/02 Buspirone Hydrochloride Tablets USP, 5 mg, 10 mg, and 15 mg, Applied Analytical Industries, ANDA 75-388 7/26/00 10/30/00 Buspirone Hydrochloride Tablets USP, 5 mg, 10 mg, and 15 mg, 2/15/00 Applied Analytical Industries, ANDA 75-388 2/15/99 2/17/00 Buspirone Hydrochloride Tablets USP, 5 mg, 10 & 15 mg, Geneva ANDA 75-413 3/19/02 4/10/03 Buspirone Hydrochloride Tablets USP,5 mg, 10 mg, and 15 mg. 12/21/99 Geneva ANDA 75-413 12/21/99 12/23/99 Buspirone Hydrochloride Tablets USP,5 mg, 10 mg, and 15 mg. Second 5/23/00 Geneva ANDA 75-413 5/23/00 5/31/00 Buspirone Hydrochloride Tablets USP, 5, 10, & 15 mg, Par Pharmaceutical, ANDA 75-467/S4 & S5 2/28/02 4/10/03 Buspirone Hydrochloride Tablets USP, 5, 7.5, 10 & 15 mg, Par Pharmaceutical, ANDA 75-467 3/28/01 3/30/01 7/17/02 Buspirone Hydrochloride Tablets USP, 5 mg, 7.5 mg, 10 mg, and 15 mg. Par Pharmaceutical, ANDA 75-467 12/28/99 1/3/00 Buspirone Hydrochloride Tablets USP, 5 mg, 7.5 mg, 10 mg, and 15 mg. Second 5/23/00 Par Pharmaceutical, ANDA 75-467 5/23/00 5/31/00 Buspirone Hydrochloride Tablets USP, 5 mg, 10 mg, and 15 mg., Torpharm ANDA 75-521 4/5/02 4/10/02 Buspirone Hydrochloride Tablets USP, 5 mg, 10 mg, and 15 mg., Torpharm ANDA 75-521 5/9/01 6/5/01 Buspirone Hydrochloride Tablets USP, 5 mg, 10 mg, and 15 mg., KV Pharmaceutical, Co. ANDA 75-572 2/27/02 4/10/03 Buspirone Hydrochloride Tablets USP, 5 mg, 10 mg, and 15 mg. 8/4/00 KV Pharmaceutical, Co. ANDA 75-572 BUSPIRONE HYDROCHLORIDE Tablet; 10MG BUSPAR BRISTOL MYERS SQUIBB 018731 BUSPIRONE HYDROCHLORIDE Tablet; 15MG BUSPAR BRISTOL MYERS SQUIBB 018731 BUSPIRONE HYDROCHLORIDE Tablet; 30MG BUSPAR BRISTOL MYERS SQUIBB 018731 BUSPIRONE HYDROCHLORIDE Tablet; 5MG BUSPAR BRISTOL MYERS SQUIBB 075119 BUSPIRONE HYDROCHLORIDE Tablet; 10MG BUSPIRONE HCL Egis 075119 BUSPIRONE HYDROCHLORIDE Tablet; 15MG BUSPIRONE HCL Egis 075119 BUSPIRONE HYDROCHLORIDE Tablet; 5MG BUSPIRONE HCL Egis 075413 BUSPIRONE HYDROCHLORIDE Tablet; 10MG BUSPIRONE HCL Geneva 075413 BUSPIRONE HYDROCHLORIDE Tablet; 15MG BUSPIRONE HCL Geneva 075413 BUSPIRONE HYDROCHLORIDE Tablet; 5MG BUSPIRONE HCL Geneva 075572 BUSPIRONE HYDROCHLORIDE Tablet; 10MG BUSPIRONE HCL KV 075572 BUSPIRONE HYDROCHLORIDE Tablet; 15MG BUSPIRONE HCL KV 075572 BUSPIRONE HYDROCHLORIDE Tablet; 5MG BUSPIRONE HCL KV 075272 BUSPIRONE HYDROCHLORIDE Tablet; 10MG BUSPIRONE HCL Mylan 075272 BUSPIRONE HYDROCHLORIDE Tablet; 15MG BUSPIRONE HCL Mylan 076008 BUSPIRONE HYDROCHLORIDE Tablet; 30MG BUSPIRONE HCL Mylan 075272 BUSPIRONE HYDROCHLORIDE Tablet; 5MG BUSPIRONE HCL Mylan 075467 BUSPIRONE HYDROCHLORIDE Tablet; 10MG BUSPIRONE HCL Par 075467 BUSPIRONE HYDROCHLORIDE Tablet; 15MG BUSPIRONE HCL Par 075467 BUSPIRONE HYDROCHLORIDE Tablet; 5MG BUSPIRONE HCL Par 075467 BUSPIRONE HYDROCHLORIDE Tablet; 7.5MG BUSPIRONE HCL Par 075388 BUSPIRONE HYDROCHLORIDE Tablet; 10MG BUSPIRONE HCL PHARMEX PRODS 075388 BUSPIRONE HYDROCHLORIDE Tablet; 15MG BUSPIRONE HCL PHARMEX PRODS 075388 BUSPIRONE HYDROCHLORIDE Tablet; 5MG BUSPIRONE HCL PHARMEX PRODS 075022 BUSPIRONE HYDROCHLORIDE Tablet; 10MG BUSPIRONE HCL Teva 075022 BUSPIRONE HYDROCHLORIDE Tablet; 15MG BUSPIRONE HCL Teva 075022 BUSPIRONE HYDROCHLORIDE Tablet; 5MG BUSPIRONE HCL Teva 075521 BUSPIRONE HYDROCHLORIDE Tablet; 10MG BUSPIRONE HCL Torpharm 075521 BUSPIRONE HYDROCHLORIDE Tablet; 15MG BUSPIRONE HCL Torpharm 075521 BUSPIRONE HYDROCHLORIDE Tablet; 5MG BUSPIRONE HCL Torpharm 074253 BUSPIRONE HYDROCHLORIDE Tablet; 10MG BUSPIRONE HCL Watson 074253 BUSPIRONE HYDROCHLORIDE Tablet; 15MG BUSPIRONE HCL Watson 074253 BUSPIRONE HYDROCHLORIDE Tablet; 5MG BUSPIRONE HCL Watson 075385 BUSPIRONE HYDROCHLORIDE Tablet; 10MG BUSPIRONE HCL ZENITH GOLDLINE 075385 BUSPIRONE HYDROCHLORIDE Tablet; 15MG BUSPIRONE HCL ZENITH GOLDLINE 075385 BUSPIRONE HYDROCHLORIDE Tablet; 5MG BUSPIRONE HCL ZENITH GOLDLINE Buspirone Hydrochloride Tablets USP, Teva Pharmaceuticals

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