Key Data Files for this Active Pharmaceutical Ingredient:

Drug Master Files, 21 CFR, and other industry portals Patent/Exclusivity data file Drug Approval Drug Safety Freedom of Information Federal Register pages Pharma Companies Pharmacopeial Information Preferred API Supplier (Clients Only)

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   For the latest approval information, locate this drug using this index.