FDA — authorised 5 May 1987
- Application: NDA019229
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: ZINC SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Zinc gluconate supplement in United States
FDA authorised Zinc gluconate supplement on 5 May 1987
Marketing authorisations
FDA — authorised 18 July 2019
- Application: NDA209377
- Marketing authorisation holder: AM REGENT
- Local brand name: ZINC SULFATE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 3 May 2022
- Application: ANDA216249
- Marketing authorisation holder: GLAND
- Local brand name: ZINC SULFATE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 27 December 2022
- Application: ANDA216145
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: ZINC SULFATE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 22 August 2023
- Application: ANDA217074
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: ZINC SULFATE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 10 June 2024
- Application: ANDA218059
- Marketing authorisation holder: APOTEX
- Local brand name: ZINC SULFATE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 5 July 2024
- Application: ANDA214597
- Marketing authorisation holder: NIVAGEN PHARMS INC
- Local brand name: ZINC SULFATE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 17 July 2024
- Application: ANDA216135
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Local brand name: ZINC SULFATE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 1 May 2025
- Application: ANDA219585
- Marketing authorisation holder: ASPIRO
- Local brand name: ZINC SULFATE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 10 June 2025
- Application: ANDA217624
- Marketing authorisation holder: STIRA
- Local brand name: ZINC SULFATE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
Frequently asked questions
Is Zinc gluconate supplement approved in United States?
Yes. FDA authorised it on 5 May 1987; FDA authorised it on 18 July 2019; FDA authorised it on 3 May 2022.
Who is the marketing authorisation holder for Zinc gluconate supplement in United States?
ABRAXIS PHARM holds the US marketing authorisation.