FDA — authorised 13 July 1950
- Application: NDA007513
- Marketing authorisation holder: HOSPIRA
- Local brand name: LEVOPHED
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Levophed in United States
FDA authorised Levophed on 13 July 1950 · 2,502 US adverse-event reports
Marketing authorisations
FDA — authorised 30 September 2004
- Application: ANDA040522
- Marketing authorisation holder: METRICS PHARM
- Local brand name: NOREPINEPHRINE BITARTRATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 August 2015
- Application: ANDA040455
- Marketing authorisation holder: MEITHEAL
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 4 October 2018
- Application: ANDA211242
- Marketing authorisation holder: MYLAN LABS LTD
- Status: approved
FDA — authorised 18 October 2018
- Application: ANDA211359
- Marketing authorisation holder: SANDOZ
- Local brand name: NOREPINEPHRINE BITARTRATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 November 2018
- Application: ANDA203662
- Marketing authorisation holder: HIKMA
- Local brand name: NOREPINEPHRINE BITARTRATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 December 2018
- Application: ANDA210839
- Marketing authorisation holder: AMNEAL
- Status: approved
FDA — authorised 3 November 2020
- Application: ANDA211382
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: NOREPINEPHRINE BITARTRATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 January 2021
- Application: NDA214313
- Marketing authorisation holder: BAXTER HLTHCARE CORP
- Local brand name: NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 22 January 2021
- Application: ANDA214455
- Marketing authorisation holder: BRECKENRIDGE
- Local brand name: NOREPINEPHRINE BITARTRATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 January 2021
- Application: ANDA211980
- Marketing authorisation holder: SUN PHARM
- Local brand name: NOREPINEPHRINE BITARTRATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 6 May 2021
- Application: ANDA214323
- Marketing authorisation holder: GLAND
- Local brand name: NOREPINEPHRINE BITARTRATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 September 2022
- Application: NDA215700
- Marketing authorisation holder: INFORLIFE
- Local brand name: NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 6 October 2022
- Application: NDA214628
- Marketing authorisation holder: LONG GROVE PHARMS
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
FDA — authorised 15 September 2023
- Application: ANDA217575
- Marketing authorisation holder: CAPLIN
- Status: approved
FDA — authorised 13 May 2024
- Application: ANDA218758
- Marketing authorisation holder: RISING
- Local brand name: NOREPINEPHRINE BITARTRATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 January 2025
- Application: ANDA219163
- Marketing authorisation holder: ASPIRO
- Local brand name: NOREPINEPHRINE BITARTRATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 March 2025
- Application: ANDA219443
- Marketing authorisation holder: BIOCON PHARMA
- Local brand name: NOREPINEPHRINE BITARTRATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 November 2025
- Application: ANDA219924
- Marketing authorisation holder: ANTHEA PHARMA
- Local brand name: NOREPINEPHRINE BITARTRATE
- Indication: INJECTABLE — INJECTION
- Status: approved
The FDA approved ANTHEA PHARMA's application (ANDA219924) for Levophed (Norepinephrine Bitartrate) injection on November 25, 2025. This approval allows ANTHEA PHARMA to market and distribute Levophed in the United States. Levophed is indicated for use as an injectable solution.
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 2,502
Most-reported reactions
- Renal Failure — 341 reports (13.63%)
- Pain — 321 reports (12.83%)
- Injury — 283 reports (11.31%)
- Anxiety — 267 reports (10.67%)
- Unevaluable Event — 255 reports (10.19%)
- Fear — 237 reports (9.47%)
- Emotional Distress — 223 reports (8.91%)
- Renal Injury — 198 reports (7.91%)
- Death — 191 reports (7.63%)
- Stress — 186 reports (7.43%)
Levophed 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 Levophed approved in United States?
Yes. FDA authorised it on 13 July 1950; FDA authorised it on 30 September 2004; FDA authorised it on 31 August 2015.
Who is the marketing authorisation holder for Levophed in United States?
HOSPIRA holds the US marketing authorisation.