🇺🇸 Hispril in United States

Hispril (DIPHENYLPYRALINE) regulatory status in United States.

Marketing authorisations

FDA

  • Marketing authorisation holder: GLAXOSMITHKLINE
  • Status: approved

FDA

  • Application: NDA011945
  • Marketing authorisation holder: GLAXOSMITHKLINE
  • Local brand name: HISPRIL
  • Indication: CAPSULE, EXTENDED RELEASE — ORAL
  • Status: approved

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Hispril in other countries

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

Other Infectious Disease approved in United States

Frequently asked questions

Is Hispril approved in United States?

Yes. FDA has authorised it; FDA has authorised it.

Who is the marketing authorisation holder for Hispril in United States?

GLAXOSMITHKLINE holds the US marketing authorisation.