🇺🇸 Bactocill In Plastic Container in United States

FDA authorised Bactocill In Plastic Container on 26 October 1989 · 550 US adverse-event reports

Marketing authorisations

FDA — authorised 26 October 1989

  • Application: NDA050640
  • Marketing authorisation holder: BAXTER HLTHCARE
  • Local brand name: BACTOCILL IN PLASTIC CONTAINER
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 18 January 2013

  • Application: ANDA201538
  • Marketing authorisation holder: EUGIA PHARMA SPECLTS
  • Local brand name: Bactocill In Plastic Container
  • Status: supplemented

FDA — authorised 18 January 2013

  • Application: ANDA201539
  • Marketing authorisation holder: EUGIA PHARMA SPECLTS
  • Local brand name: Bactocill In Plastic Container
  • Status: supplemented

FDA — authorised 20 July 2020

  • Application: ANDA206198
  • Marketing authorisation holder: FRESENIUS KABI USA
  • Local brand name: Bactocill In Plastic Container
  • Status: approved

FDA — authorised 27 July 2020

  • Application: ANDA206199
  • Marketing authorisation holder: FRESENIUS KABI USA
  • Local brand name: Bactocill In Plastic Container
  • Status: approved

FDA

  • Status: approved

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.

Most-reported reactions

  1. Drug Ineffective — 88 reports (16%)
  2. Drug Reaction With Eosinophilia And Systemic Symptoms — 68 reports (12.36%)
  3. Acute Kidney Injury — 63 reports (11.45%)
  4. Pyrexia — 61 reports (11.09%)
  5. Rash — 56 reports (10.18%)
  6. Off Label Use — 46 reports (8.36%)
  7. Drug Interaction — 43 reports (7.82%)
  8. Toxic Epidermal Necrolysis — 43 reports (7.82%)
  9. Pneumonia — 41 reports (7.45%)
  10. Renal Failure — 41 reports (7.45%)

Source database →

Other Cardiovascular approved in United States

Frequently asked questions

Is Bactocill In Plastic Container approved in United States?

Yes. FDA authorised it on 26 October 1989; FDA authorised it on 18 January 2013; FDA authorised it on 18 January 2013.

Who is the marketing authorisation holder for Bactocill In Plastic Container in United States?

BAXTER HLTHCARE holds the US marketing authorisation.