🇺🇸 Zolpidem CR 12.5mg in United States

Zolpidem CR 12.5mg (Zolpidem CR 12.5mg) regulatory status in United States.

Marketing authorisation

FDA

  • Status: approved

Zolpidem CR 12.5mg 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 Zolpidem CR 12.5mg approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Zolpidem CR 12.5mg in United States?

Associação Fundo de Incentivo à Pesquisa is the originator. The local marketing authorisation holder may differ — check the official source linked above.