🇺🇸 carbamazepine ER in United States

FDA authorised carbamazepine ER on 15 August 2025

Marketing authorisation

FDA — authorised 15 August 2025

  • Application: ANDA215591
  • Marketing authorisation holder: ZHEJIANG JIUZHOU
  • Indication: Labeling
  • Status: approved

The FDA approved carbamazepine ER for marketing in the United States on 15 August 2025. The approval was granted to ZHEJIANG JIUZHOU under application number ANDA215591. Carbamazepine ER is an extended-release formulation of the anticonvulsant medication carbamazepine.

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carbamazepine ER in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is carbamazepine ER approved in United States?

Yes. FDA authorised it on 15 August 2025.

Who is the marketing authorisation holder for carbamazepine ER in United States?

ZHEJIANG JIUZHOU holds the US marketing authorisation.