FDA — authorised 24 February 2000
- Application: NDA019892
- Marketing authorisation holder: RHODES PHARMS
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 Dilaudid-Hp in United States
FDA authorised Dilaudid-Hp on 24 February 2000
Marketing authorisations
FDA — authorised 16 December 2016
- Application: NDA200403
- Marketing authorisation holder: HOSPIRA INC
- Indication: Labeling
- Status: approved
FDA — authorised 18 September 2018
- Application: ANDA210506
- Marketing authorisation holder: ASCENT PHARMS INC
- Indication: REMS
- Status: approved
FDA — authorised 7 April 2020
- Application: ANDA205814
- Marketing authorisation holder: AUROLIFE PHARMA LLC
- Indication: Labeling
- Status: approved
FDA — authorised 31 October 2024
- Application: ANDA210176
- Marketing authorisation holder: ASCENT PHARMS INC
- Indication: REMS
- Status: approved
The FDA approved Dilaudid-Hp, manufactured by ASCENT PHARMS INC, on 2024-10-31. The approval was granted under the standard expedited pathway. The approved indication for Dilaudid-Hp is under a Risk Evaluation and Mitigation Strategy (REMS).
Dilaudid-Hp in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Dilaudid-Hp approved in United States?
Yes. FDA authorised it on 24 February 2000; FDA authorised it on 16 December 2016; FDA authorised it on 18 September 2018.
Who is the marketing authorisation holder for Dilaudid-Hp in United States?
RHODES PHARMS holds the US marketing authorisation.