FDA — authorised 8 July 2009
- Application: ANDA090619
- Marketing authorisation holder: DR REDDYS LABS LTD
- Status: approved
🇺🇸 DIPHENHYDRAMINE in United States
FDA authorised DIPHENHYDRAMINE on 8 July 2009 · 72,890 US adverse-event reports
Marketing authorisations
FDA — authorised 22 August 2018
- Application: ANDA205723
- Marketing authorisation holder: MICRO LABS
- Indication: Labeling
- Status: approved
FDA — authorised 24 September 2020
- Application: ANDA213663
- Marketing authorisation holder: GRANULES
- Status: approved
FDA — authorised 20 March 2024
- Application: ANDA218448
- Marketing authorisation holder: GLAND
- Status: approved
FDA — authorised 24 June 2025
- Application: ANDA205336
- Marketing authorisation holder: AVET LIFESCIENCES
- Status: approved
FDA — authorised 22 August 2025
- Application: ANDA219845
- Marketing authorisation holder: MICRO LABS
- Status: approved
FDA — authorised 14 November 2025
- Application: ANDA205337
- Marketing authorisation holder: AVET LIFESCIENCES
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 72,890
Most-reported reactions
- Off Label Use — 11,078 reports (15.2%)
- Fatigue — 8,503 reports (11.67%)
- Headache — 8,012 reports (10.99%)
- Nausea — 7,504 reports (10.29%)
- Pain — 7,087 reports (9.72%)
- Drug Ineffective — 7,030 reports (9.64%)
- Infusion Related Reaction — 6,267 reports (8.6%)
- Toxicity To Various Agents — 6,003 reports (8.24%)
- Arthralgia — 5,867 reports (8.05%)
- Dyspnoea — 5,539 reports (7.6%)
DIPHENHYDRAMINE 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 DIPHENHYDRAMINE approved in United States?
Yes. FDA authorised it on 8 July 2009; FDA authorised it on 22 August 2018; FDA authorised it on 24 September 2020.
Who is the marketing authorisation holder for DIPHENHYDRAMINE in United States?
DR REDDYS LABS LTD holds the US marketing authorisation.