🇺🇸 Ramelteon and doxepin in United States

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

FDA authorised Ramelteon and doxepin on 23 September 1969

Marketing authorisation

FDA — authorised 23 September 1969

Application: NDA016798
Marketing authorisation holder: PFIZER
Local brand name: SINEQUAN
Indication: CAPSULE — ORAL
Status: approved

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Frequently asked questions

Is Ramelteon and doxepin approved in United States?

Yes. FDA authorised it on 23 September 1969.

Who is the marketing authorisation holder for Ramelteon and doxepin in United States?

PFIZER holds the US marketing authorisation.