FDA — authorised 13 February 1978
- Application: NDA018066
- Marketing authorisation holder: CHATTEM
- Local brand name: UNISOM
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Diphenhydramine HCL in United States
FDA authorised Diphenhydramine HCL on 13 February 1978
Marketing authorisations
FDA
- Application: NDA019440
- Marketing authorisation holder: PFIZER
- Local brand name: UNISOM
- Indication: CAPSULE — ORAL
- Status: approved
Other Allergy/Immunology approved in United States
Frequently asked questions
Is Diphenhydramine HCL approved in United States?
Yes. FDA authorised it on 13 February 1978; FDA has authorised it.
Who is the marketing authorisation holder for Diphenhydramine HCL in United States?
CHATTEM holds the US marketing authorisation.