FDA — authorised 30 November 1988
- Application: ANDA062638
- Marketing authorisation holder: HOSPIRA
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 Benzamycin in United States
FDA authorised Benzamycin on 30 November 1988
Marketing authorisations
FDA — authorised 9 May 1989
- Application: ANDA062993
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: ERYTHROMYCIN LACTOBIONATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 August 1994
- Application: NDA050609
- Marketing authorisation holder: HOSPIRA
- Indication: Labeling
- Status: approved
FDA — authorised 17 September 2020
- Application: ANDA211086
- Marketing authorisation holder: EXELA PHARMA
- Local brand name: ERYTHROMYCIN LACTOBIONATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 14 February 2022
- Application: ANDA215290
- Marketing authorisation holder: NEXUS
- Local brand name: ERYTHROMYCIN LACTOBIONATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 19 November 2024
- Application: ANDA216761
- Marketing authorisation holder: GLAND
- Status: approved
FDA
- Application: ANDA062604
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: ERYTHROMYCIN LACTOBIONATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA062660
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: ERYTHROMYCIN LACTOBIONATE
- Indication: Injectable — Injection
- Status: approved
Benzamycin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Benzamycin approved in United States?
Yes. FDA authorised it on 30 November 1988; FDA authorised it on 9 May 1989; FDA authorised it on 24 August 1994.
Who is the marketing authorisation holder for Benzamycin in United States?
HOSPIRA holds the US marketing authorisation.