FDA — authorised 4 February 1986
- Application: ANDA089081
- Marketing authorisation holder: TEVA
- Local brand name: PRELONE
- Indication: SOLUTION — ORAL
- Status: approved
🇺🇸 Prelone in United States
FDA authorised Prelone on 4 February 1986
Marketing authorisations
FDA — authorised 28 May 1986
- Application: NDA019157
- Marketing authorisation holder: PAI HOLDINGS
- Local brand name: PEDIAPRED
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 17 January 1989
- Application: ANDA089654
- Marketing authorisation holder: MURO
- Local brand name: PRELONE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 29 December 1995
- Application: ANDA074449
- Marketing authorisation holder: BAUSCH AND LOMB
- Status: approved
FDA — authorised 9 June 2005
- Application: ANDA075988
- Marketing authorisation holder: CHARTWELL RX
- Indication: Labeling
- Status: approved
FDA — authorised 25 October 2022
- Application: ANDA216715
- Marketing authorisation holder: AMNEAL
- Status: approved
FDA — authorised 5 June 2024
- Application: ANDA078988
- Marketing authorisation holder: PHARM ASSOC
- Indication: Labeling
- Status: approved
Prelone, a pharmaceutical product, was granted marketing authorisation by the FDA on 2024-06-05. The application number for this approval is ANDA078988. The marketing authorisation holder is PHARM ASSOC, and the product's indication is for labelling purposes.
FDA — authorised 5 June 2024
- Application: ANDA040775
- Marketing authorisation holder: LANNETT CO INC
- Indication: Labeling
- Status: approved
Lannett Co Inc has been granted marketing authorisation by the FDA for Prelone. The approval was issued on 2024-06-05 under application number ANDA040775. Prelone's indication for use is labelled, but the specific indication is not reported.
Prelone in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Prelone approved in United States?
Yes. FDA authorised it on 4 February 1986; FDA authorised it on 28 May 1986; FDA authorised it on 17 January 1989.
Who is the marketing authorisation holder for Prelone in United States?
TEVA holds the US marketing authorisation.