U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 213236
Company: ACCORD HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
REGADENOSON REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION;INTRAVENOUS Prescription AP 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
04/11/2022 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/02/2022 SUPPL-2 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

REGADENOSON

SOLUTION;INTRAVENOUS; 0.4MG/5ML (0.08MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEXISCAN REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 022161 ASTELLAS
REGADENOSON REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 213236 ACCORD HLTHCARE
REGADENOSON REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 207604 APOTEX
REGADENOSON REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 213210 DR REDDYS
REGADENOSON REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 216437 EUGIA PHARMA
REGADENOSON REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 207320 GLAND PHARMA LTD
REGADENOSON REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 214349 HOSPIRA
REGADENOSON REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 214252 IMS LTD
REGADENOSON REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 212806 MEITHEAL
Back to Top