Regulatory Updates
Sep 27, 2026•1 min read
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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Regulatory Updates
Sep 27, 2026•1 min read
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.
Regulatory Updates
Sep 25, 2026•1 min read
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.
Regulatory Updates
Sep 25, 2026•1 min read
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.