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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209646
Company: FRESENIUS KABI USA

Products on ANDA 209646

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EPHEDRINE SULFATE	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209646

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/04/2020	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
09/13/2021	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 209646

EPHEDRINE SULFATE

SOLUTION;INTRAVENOUS; 50MG/ML (50MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AKOVAZ	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	208289	EXELA PHARMA
CORPHEDRA	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	208943	PH HEALTH
EPHEDRINE SULFATE	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	212932	AMNEAL
EPHEDRINE SULFATE	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	219050	CAPLIN
EPHEDRINE SULFATE	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	215593	CIVICA
EPHEDRINE SULFATE	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	212649	DR REDDYS
EPHEDRINE SULFATE	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	214579	EUGIA PHARMA
EPHEDRINE SULFATE	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	209646	FRESENIUS KABI USA
EPHEDRINE SULFATE	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	216146	GLAND
EPHEDRINE SULFATE	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	214334	HIKMA
EPHEDRINE SULFATE	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	216129	MANKIND PHARMA
EPHEDRINE SULFATE	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	214528	SAGENT PHARMS INC
EPHEDRINE SULFATE	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	209784	SANDOZ
EPHEDRINE SULFATE	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	215825	XIROMED

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