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Drugs@FDA: FDA-Approved Drugs

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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
02/08/2024 SUPPL-4 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

08/02/2022 SUPPL-2 Labeling-Package Insert, Labeling-Container/Carton Labels

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 217455 BAXTER HLTHCARE CORP
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 215955 GE HEALTHCARE
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 215827 HIKMA
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 218054 INDIES PHARMA
REGADENOSON REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 212806 MEITHEAL
REGADENOSON REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 213856 MYLAN
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