The U.S. Food and Drug Administration (FDA) has approved an Abbreviated New Drug Application (ANDA) numbered 079159 for generic lithium carbonate capsules.
The approved products are oral capsules manufactured by Alembic Pharmaceuticals Inc. (also listed as Alembic Pharmaceuticals Limited) in three strengths: 150 mg, 300 mg, and 600 mg of lithium carbonate.
The submission history includes an original filing on 12 January 2009 and multiple labeling supplements, the most recent dated 5 January 2023.
規制動向2026年9月19日•1分で読めます
FDA Approves Alembic’s Generic Lithium Carbonate Capsules (ANDA 079159)
The FDA has granted approval for Alembic Pharmaceuticals’ generic lithium carbonate oral capsules in 150 mg, 300 mg, and 600 mg strengths under ANDA 079159.
PharmaCountryチームがまとめました · 出典： FDA.gov
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