The U.S. Food and Drug Administration has approved a series of oral extended‑release tablet products containing pramipexole dihydrochloride, identified under application number ANDA202353.
The approved products are prescription‑only tablets in five strengths: 0.375 mg (product number 001), 0.75 mg (002), 1.5 mg (003), 3 mg (004), and 4.5 mg (005). All are classified as extended‑release oral dosage forms.
The original submission (submission 1) received approval on 4 December 2014. A second original submission (submission 2) was tentatively approved on the same date. Subsequent supplemental submissions for labeling (submission numbers 1, 2, 3, 4, 6, 8) were approved on dates ranging from 22 December 2020 to 28 February 2025, all with standard review priority.
Actualizaciones regulatorias16 sept 2026•3 min de lectura
PRAMIPEXOLE DIHYDROCHLORIDE Extended‑Release Tablets Approved (ANDA202353)
FDA approved multiple oral extended‑release tablet products of pramipexole dihydrochloride under ANDA202353, covering five strengths and several labeling supplements.
Recopilado por el equipo de Pharmacountry · Fuente: FDA.gov
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