Application Information

This drug has been submitted to the FDA under the reference 074787/001.

Names and composition

"LABETALOL HYDROCHLORIDE" is the commercial name of a drug composed of LABETALOL HYDROCHLORIDE.

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
074787/001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET/ORAL 100MG
074787/002 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET/ORAL 200MG
074787/003 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET/ORAL 300MG
074989/001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET/ORAL 100MG
074989/002 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET/ORAL 200MG
074989/003 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET/ORAL 300MG
075113/001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET/ORAL 100MG
075113/002 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET/ORAL 200MG
075113/003 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET/ORAL 300MG
075133/001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET/ORAL 100MG
075133/002 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET/ORAL 200MG
075133/003 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET/ORAL 300MG
075215/001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET/ORAL 100MG
075215/002 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET/ORAL 200MG
075215/003 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET/ORAL 300MG
075223/001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET/ORAL 100MG
075223/002 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET/ORAL 200MG
075223/003 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET/ORAL 300MG
075239/001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE INJECTABLE/INJECTION 5MG per ML
075240/001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE INJECTABLE/INJECTION 5MG per ML
075242/001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE INJECTABLE/INJECTION 5MG per ML
075303/001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE INJECTABLE/INJECTION 5MG per ML
075355/001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE INJECTABLE/INJECTION 5MG per ML
075431/001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE INJECTABLE/INJECTION 5MG per ML
075524/001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE INJECTABLE/INJECTION 5MG per ML
076051/001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE INJECTABLE/INJECTION 5MG per ML
079134/001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE INJECTABLE/INJECTION 5MG per ML
090699/001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE INJECTABLE/INJECTION 5MG per ML
200908/001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET/ORAL 100MG
200908/002 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET/ORAL 200MG
200908/003 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET/ORAL 300MG

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
018686/001 NORMODYNE LABETALOL HYDROCHLORIDE INJECTABLE/INJECTION 5MG per ML
018687/001 NORMODYNE LABETALOL HYDROCHLORIDE TABLET/ORAL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
018687/002 NORMODYNE LABETALOL HYDROCHLORIDE TABLET/ORAL 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
018687/003 NORMODYNE LABETALOL HYDROCHLORIDE TABLET/ORAL 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
018687/004 NORMODYNE LABETALOL HYDROCHLORIDE TABLET/ORAL 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
018716/001 TRANDATE LABETALOL HYDROCHLORIDE TABLET/ORAL 100MG
018716/002 TRANDATE LABETALOL HYDROCHLORIDE TABLET/ORAL 200MG
018716/003 TRANDATE LABETALOL HYDROCHLORIDE TABLET/ORAL 300MG
018716/004 TRANDATE LABETALOL HYDROCHLORIDE TABLET/ORAL 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
019425/001 TRANDATE LABETALOL HYDROCHLORIDE INJECTABLE/INJECTION 5MG per ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
074787/001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET/ORAL 100MG
074787/002 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET/ORAL 200MG
074787/003 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET/ORAL 300MG
074989/001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET/ORAL 100MG
074989/002 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET/ORAL 200MG
074989/003 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET/ORAL 300MG
075113/001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET/ORAL 100MG
075113/002 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET/ORAL 200MG
075113/003 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET/ORAL 300MG
075133/001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET/ORAL 100MG
075133/002 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET/ORAL 200MG
075133/003 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET/ORAL 300MG
075215/001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET/ORAL 100MG
075215/002 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET/ORAL 200MG
075215/003 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET/ORAL 300MG
075223/001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET/ORAL 100MG
075223/002 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET/ORAL 200MG
075223/003 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET/ORAL 300MG
075239/001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE INJECTABLE/INJECTION 5MG per ML
075240/001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE INJECTABLE/INJECTION 5MG per ML
075242/001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE INJECTABLE/INJECTION 5MG per ML
075303/001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE INJECTABLE/INJECTION 5MG per ML
075355/001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE INJECTABLE/INJECTION 5MG per ML
075431/001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE INJECTABLE/INJECTION 5MG per ML
075524/001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE INJECTABLE/INJECTION 5MG per ML
076051/001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE INJECTABLE/INJECTION 5MG per ML
079134/001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE INJECTABLE/INJECTION 5MG per ML
090699/001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE INJECTABLE/INJECTION 5MG per ML
200908/001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET/ORAL 100MG
200908/002 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET/ORAL 200MG
200908/003 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET/ORAL 300MG

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