Arca
Skip to content

Cisatracurium Besylate

ANDA 203236, held by Hospira. Cisatracurium Besylate.

  • First approved: Mar 30, 2018
  • Supplements approved: 4
  • Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below
DateSubmissionStatusDocuments
Mar 30, 2018Original applicationApprovedNone posted

Products

2 strengths and forms
ProductActive ingredientMarketing
Cisatracurium BesylateEQ 2MG BASE/ML · injectable;injectionCisatracurium BesylateRx
Cisatracurium BesylateEQ 10MG BASE/ML · injectable;injectionCisatracurium BesylateRx
All 5 submissions, including labeling and manufacturing supplements
DateSubmissionStatusDocuments
Sep 18, 2023Supplement 12Labeling · Standard reviewApprovedNone posted
May 29, 2020Supplement 6Labeling · Standard reviewApprovedNone posted
May 29, 2020Supplement 2Labeling · Standard reviewApprovedNone posted
May 29, 2020Supplement 1Labeling · Standard reviewApprovedNone posted
Mar 30, 2018Original applicationApprovedNone posted

Identifiers

Application
ANDA 203236
Company
Hospira

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters

Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.