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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213236
Company: ACCORD HLTHCARE

Products on ANDA 213236

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213236

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.

Therapeutic Equivalents for ANDA 213236

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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