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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207604
Company: APOTEX

Products on ANDA 207604

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 207604

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	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/207604Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 207604

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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