The U.S. Food and Drug Administration has approved application ANDA 076648 for an oral capsule product containing nitrofurantoin monohydrate and macrocrystalline forms. The product, identified as Nitrofurantoin (Monohydrate/Macrocrystals) capsule, is manufactured by Chartwell Rx and is listed with product number 001.
The capsule delivers two active ingredients: nitrofurantoin 75 mg and nitrofurantoin macrocrystalline 25 mg. It is administered orally and is classified as a discontinued marketing status, with no reference drug listed.
The approval timeline includes an original submission (submission 1) approved on 22 Mar 2004, accompanied by an original approval package and a FDA letter dated 24 Mar 2004. Subsequent labeling supplements were approved on 24 Jul 2008 (submission 4), 20 Nov 2012 (submission 6), and 16 Feb 2016 (submission 8), all under standard review priority.
Regulatorische Updates17. Sept. 2026•3 Min. Lesezeit
FDA Approves ANDA 076648 for Nitrofurantoin Oral Capsules (Monohydrate/Macrocrystals)
The FDA granted approval for ANDA 076648, covering nitrofurantoin (75 mg + 25 mg macrocrystalline) oral capsules marketed by Chartwell Rx.
Zusammengestellt vom Pharmacountry-Team · Quelle: FDA.gov
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