LEVETIRACETAM IN SODIUM CHLORIDE

FDA-2024-P-3188

Lachman Consulting Services, Inc. filed this suitability petition on July 3, 2024, requesting that the FDA declare Levetiracetam in Sodium Chloride Injection, 1250 mg/100 mL (12.5 mg/mL) suitable for submission as an ANDA under Section 505(j)(2)(C) of the FD&C Act, with the reference listed drug bei

FDA-2020-P-1393

Nexus Pharmaceuticals Inc. filed a petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting permission to submit an Abbreviated New Drug Application for Levetiracetam in Sodium Chloride Injection at a new strength of 750 mg/100 mL (7.5 mg/mL), which differs from the

FDA-2020-P-1393

Nexus Pharmaceuticals Inc filed this suitability petition under section 505(j)(2)(C) requesting FDA approval to submit an ANDA or Prior Approval Supplement for Levetiracetam in Sodium Chloride injection at an intermediate 750 mg/100 mL strength, which differs from the reference listed drug NDA 20254

FDA-2019-P-5760

Sun Pharmaceutical Industries Limited filed this suitability petition on December 6, 2019, pursuant to section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act, requesting FDA determination that Levetiracetam in Sodium Chloride Injection in a new strength of 2.5 mg/mL (250 mg/100 mL) is suit