The FDA's NDA050306 filing, submitted by sponsor ROERIG, pertains to the GEOPEN brand injectable products containing carbenicillin disodium.
The record lists five products (product numbers 001, 002, 004, 006, 007) each with a specific strength: 1 g, 2 g, 5 g, 10 g, and 30 g base per vial. All are classified as injections, dosage form injectable, and have a marketing status of "Discontinued".
No reference drug status or reference standard is indicated for any of the products.
規制動向2026年9月17日•3分で読めます
FDA NDA050306: Discontinued GEOPEN Injectable Carbenicillin Products
The FDA record NDA050306 lists five GEOPEN injectable carbenicillin products, all marked discontinued.
Pharmacountryチームがまとめました · 出典： FDA.gov
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