FDA — authorised 29 December 1981
- Application: NDA050545
- Marketing authorisation holder: WYETH PHARMS INC
- Local brand name: PIPRACIL
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Pipracil in United States
FDA authorised Pipracil on 29 December 1981
Marketing authorisations
FDA — authorised 29 December 1981
- Status: approved
FDA — authorised 14 November 2003
- Application: ANDA065114
- Marketing authorisation holder: ISTITUTO BIO ITA SPA
- Local brand name: PIPERACILLIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 12 July 2004
- Application: ANDA065157
- Marketing authorisation holder: ISTITUTO BIO ITA SPA
- Local brand name: PIPERACILLIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 August 2019
- Application: ANDA065498
- Marketing authorisation holder: EUGIA PHARMA SPECLTS
- Indication: Labeling
- Status: approved
FDA — authorised 14 October 2020
- Application: ANDA065523
- Marketing authorisation holder: ISTITUTO BIO ITA SPA
- Indication: Labeling
- Status: approved
FDA — authorised 3 January 2024
- Application: ANDA204959
- Marketing authorisation holder: SHANDONG
- Indication: Labeling
- Status: approved
The FDA approved Pipracil, a drug product, for labeling indication on January 3, 2024. The marketing authorization was granted to SHANDONG under the standard expedited pathway. The application number for this approval is ANDA204959.
FDA — authorised 1 May 2024
- Application: ANDA065458
- Marketing authorisation holder: ONESOURCE SPECIALTY
- Indication: Labeling
- Status: approved
ONESOURCE SPECIALTY has been granted marketing authorisation by the FDA for Pipracil. Pipracil is approved for the indication specified in its labelling. The marketing authorisation was granted on 2024-05-01 under application number ANDA065458.
FDA — authorised 3 April 2025
- Application: NDA206056
- Marketing authorisation holder: B BRAUN MEDICAL
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
The FDA approved Pipracil, a drug manufactured by B Braun Medical, on 3 April 2025. This approval was granted under a standard expedited pathway for a new formulation or manufacturer, as indicated by the Type 5 approval category. The application number for this approval is NDA206056.
Pipracil in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Pipracil approved in United States?
Yes. FDA authorised it on 29 December 1981; FDA authorised it on 29 December 1981; FDA authorised it on 14 November 2003.
Who is the marketing authorisation holder for Pipracil in United States?
WYETH PHARMS INC holds the US marketing authorisation.