U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 090194
Company: HOSPIRA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 20MG/10ML (2MG/ML) SOLUTION;INJECTION Discontinued None No No
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION;INJECTION Discontinued None No No
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION;INJECTION Discontinued None No No
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION;INJECTION Discontinued None No No
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION;INJECTION Discontinued None No No
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION;INJECTION Discontinued None No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/23/2014 ORIG-1 Approval

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/23/2023 SUPPL-5 Labeling-Patient Package Insert

Label is not available on this site.
05/23/2023 SUPPL-2 Labeling-Package Insert

Label is not available on this site.
Back to Top