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FDA approval · 2022-02-18

FDA Approved: NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) — Original Application (Jubilant Cadista Pharmaceuticals Inc.)

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Summary

FDA approved Jubilant Cadista Pharmaceuticals' generic nitrofurantoin monohydrate/macrocrystals (ANDA) as a bioequivalent generic product.

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Diseases / indications

Drugs mentioned

  • Nitrofurantoin (monohydrate/macrocrystals) (Nitrofurantoin monohydrate/macrocystals)

Snippet

ORIG AP for NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) (NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS))