Actualizaciones regulatorias
Novedades regulatorias de FDA, EMA, TGA y organismos globales
#Lorazepam ×
Actualizaciones regulatorias
27 sept 2026•1 min de lectura
FDA Approves Leading Pharma’s Lorazepam Tablet ANDA078203
The FDA has approved ANDA078203 for Lorazepam tablets (0.5 mg, 1 mg, 2 mg) manufactured by Leading Pharma, LLC.
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Actualizaciones regulatorias
27 sept 2026•1 min de lectura
FDA Approves ANDA077076 for Lorazepam Injectable Products
FDA approved ANDA077076 submitted by Bedford for Lorazepam injectable products (2 mg/mL and 4 mg/mL), both listed as discontinued.
Actualizaciones regulatorias
25 sept 2026•1 min de lectura
FDA ANDA077657: Lorazepam Tablet Discontinuations and Submission History
The FDA’s ANDA077657 for lorazepam tablets (0.5 mg, 1 mg, 2 mg) lists all products as discontinued and details several supplemental labeling submissions.
Actualizaciones regulatorias
25 sept 2026•1 min de lectura
FDA Approves Lorazepam Injectable (ATIVAN) NDA018140
The FDA granted approval for NDA018140, authorizing Lorazepam injectable (brand name ATIVAN) from Hikma Pharmaceuticals USA and Civica, Inc.