The FDA announced approval of NDA 017830 for the oral prescription drug carbidopa, marketed under the brand names CARBIDOPA and Lodosyn. The product is a 25 mg tablet administered orally.
The application lists two manufacturers, Oceanside Pharmaceuticals and Bausch Health US, LLC. The drug is classified as a human prescription drug and belongs to the DOPA decarboxylase inhibitor class.
FDA submissions included labeling approvals (submission numbers 16, 18, 30) with status “AP” on 21 Feb 2014, and a priority manufacturing (CMC) submission (number 24) approved on 18 Dec 2002. Links to the FDA labeling and approval letters are provided in the submission records.
The product is identified by NDC codes 68682‑200‑25 and 25010‑711‑15, and is listed under route “ORAL”. It is designated as a reference drug and carries a prescription marketing status.
Actualités réglementaires15 sept. 2026•3 min de lecture
FDA approves NDA 017830 for Lodosyn (carbidopa) oral tablets
The FDA granted approval for NDA 017830, authorizing the prescription oral tablet Lodosyn (carbidopa) from Bausch Health US and Oceanside Pharmaceuticals.
Compilé par l'équipe Pharmacountry · Source : FDA.gov
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