FDA Approves Alembic’s Nitrofurantoin Generic Capsules (ANDA211935)

The U.S. Food and Drug Administration (FDA) has granted approval for application ANDA211935, submitted by Alembic Pharmaceuticals. The approval covers generic Nitrofurantoin capsules manufactured by Alembic Pharmaceuticals Limited and Alembic Pharmaceuticals Inc. The approved products are oral capsules available in three strengths: 25 mg, 50 mg, and 100 mg of Nitrofurantoin, macrocrystalline. All three dosage forms are classified as prescription human drugs and carry the marketing status "Prescription." The products are identified by multiple NDC numbers, including 46708‑389‑31, 46708‑390‑31, 46708‑391‑31, 62332‑389‑31, 62332‑390‑31, and 62332‑391‑31. The submissions were reviewed under standard priority, with the original submission (submission number 1) receiving an approved status on June 25 2021. Nitrofurantoin is classified under the Nitrofurans pharmacologic class and is indicated as an oral antibacterial agent.