FDA Approval Activities for this Drug…

Labetalol Hydrochloride Injection USP, 5 mg/mL, 4mL, 8 mL, 20 mL & 40 mL vials, Apotex Corp. ANDA 76-051 7/5/02 Labetalol Hydrochloride Injection USP, 5 mg/mL (20 mL & 40 mL vials). Bedford Laboratorie ANDA 75-303 5/28/99 6/1/99 Labetalol Hydrochloride Tablets USP, 100 mg, 200 mg, 300 mg, Mutual Pharmaceutical Company, ANDA 75-215 7/29/99 7/29/99 Labetalol Hydrochloride Injection USP, 5 mg/mL (Multiple-Dose Vials) Faulding Pharmaceutical Co. ANDA 75-242 9/30/99 10/4/99 Labetalol Hydrochloride Injection USP, 5 mg/mL (Multiple-Dose Vials) 12/29/1998 Faulding Pharmaceutical Co. ANDA 75-242 12/29/98 12/29/98 Labetalol Hydrochloride Injection USP, 5 mg/mL (Carpuject) 11/27/1998 Abbott ANDA 75-239 11/27/98 11/27/98 Labetalol Hydrochloride Injection USP, 5 mg/mL (Carpuject) Abbott ANDA 75-239 11/29/99 12/29/99 Labetalol Hydrochloride Injection USP, 5 mg/mL (Multiple Dose Vials) 11/27/1998 Abbott ANDA 75-240 11/27/98 11/27/98 Labetalol Hydrochloride Injection USP, 5 mg/mL (Multiple Dose Vials) Abbott ANDA 75-240 11/29/99 12/29/99 Labetalol Hydrochloride Injection USP, 5mg/mL, 2/23/1999 Apothecon, ANDA 75-355 2/23/99 3/04/99 Labetalol Hydrochloride Injection USP, 5mg/mL, Apothecon, ANDA 75-355 11/29/99 12/29/99 Labetalol Hydrochloride Injection USP, 5mg/mL, Taylor ANDA 75-431 12/29/99 12/29/99 Labetalol Hydrochloride Injection USP, 5mg/mL, Taylor ANDA 75-524 11/29/99 12/29/99 Labetalol Hydrochloride Tablets USP, 100 mg, 200 mg, and 300 mg, Apothecon, ANDA 75-223 11/23/98 11/23/98 Labetalol Hydrochloride Tablets USP, 100 mg, 200 mg, and 300 mg, Eon Manufacturing ANDA 75-113 8/4/98 9/8/98 Labetalol Hydrochloride Tablets USP, 100 mg, 200 mg, 300 mg, Teva USA ANDA 74-989 9/30/98 9/30/98 9/25/02 Labetalol Hydrochloride Tablets USP, 100 mg, 200 mg, 300 mg, Watson ANDA 75-133 8/3/98 8/7/98 9/25/02 Labetalol Hydrochloride Tablets USP, 100 mg, 200 mg and 300 mg, Zenith Goldline ANDA 74-787 Trandate (labetalol hydrochloride) Tablets, 100 mg, 200 mg and 300 mg, Prometheus NDA 18-716/S-023 LABETALOL HYDROCHLORIDE Injection 5MG/ML LABETALOL HCL Abbott 075240 LABETALOL HYDROCHLORIDE Injection 5MG/ML LABETALOL HCL Abbott 076051 LABETALOL HYDROCHLORIDE Injection 5MG/ML LABETALOL HCL Apotex 075303 LABETALOL HYDROCHLORIDE Injection 5MG/ML LABETALOL HCL Bedford 075242 LABETALOL HYDROCHLORIDE Injection 5MG/ML LABETALOL HCL Faulding 019425 LABETALOL HYDROCHLORIDE Injection 5MG/ML TRANDATE Prometheus 018686 LABETALOL HYDROCHLORIDE Injection 5MG/ML NORMODYNE SCHERING 075431 LABETALOL HYDROCHLORIDE Injection 5MG/ML LABETALOL HCL TAYLOR 075524 LABETALOL HYDROCHLORIDE Injection 5MG/ML LABETALOL HCL TAYLOR 075223 LABETALOL HYDROCHLORIDE Tablet; 100MG LABETALOL HCL APOTHECON 075223 LABETALOL HYDROCHLORIDE Tablet; 200MG LABETALOL HCL APOTHECON 075223 LABETALOL HYDROCHLORIDE Tablet; 300MG LABETALOL HCL APOTHECON 075113 LABETALOL HYDROCHLORIDE Tablet; 100MG LABETALOL HCL Eon 075113 LABETALOL HYDROCHLORIDE Tablet; 200MG LABETALOL HCL Eon 075113 LABETALOL HYDROCHLORIDE Tablet; 300MG LABETALOL HCL Eon 074787 LABETALOL HYDROCHLORIDE Tablet; 100MG LABETALOL HCL Ivax 074787 LABETALOL HYDROCHLORIDE Tablet; 200MG LABETALOL HCL Ivax 074787 LABETALOL HYDROCHLORIDE Tablet; 300MG LABETALOL HCL Ivax 075215 LABETALOL HYDROCHLORIDE Tablet; 100MG LABETALOL HCL Mutual 075215 LABETALOL HYDROCHLORIDE Tablet; 200MG LABETALOL HCL Mutual 075215 LABETALOL HYDROCHLORIDE Tablet; 300MG LABETALOL HCL Mutual 018716 LABETALOL HYDROCHLORIDE Tablet; 100MG TRANDATE Prometheus 018716 LABETALOL HYDROCHLORIDE Tablet; 200MG TRANDATE Prometheus 018716 LABETALOL HYDROCHLORIDE Tablet; 300MG TRANDATE Prometheus 018687 LABETALOL HYDROCHLORIDE Tablet; 100MG NORMODYNE SCHERING 018687 LABETALOL HYDROCHLORIDE Tablet; 200MG NORMODYNE SCHERING 018687 LABETALOL HYDROCHLORIDE Tablet; 300MG NORMODYNE SCHERING 074989 LABETALOL HYDROCHLORIDE Tablet; 100MG LABETALOL HCL Teva 074989 LABETALOL HYDROCHLORIDE Tablet; 200MG LABETALOL HCL Teva 074989 LABETALOL HYDROCHLORIDE Tablet; 300MG LABETALOL HCL Teva 075133 LABETALOL HYDROCHLORIDE Tablet; 100MG LABETALOL HCL Watson 075133 LABETALOL HYDROCHLORIDE Tablet; 200MG LABETALOL HCL Watson 075133 LABETALOL HYDROCHLORIDE Tablet; 300MG LABETALOL HCL Watson

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