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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208289
Company: EXELA PHARMA

Summary Review

Products on NDA 208289

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AKOVAZ	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	Yes	Yes
AKOVAZ	EPHEDRINE SULFATE	25MG/5ML (5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208289

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/29/2016	ORIG-1	Approval	Type 7 - Drug Already Marketed without Approved NDA	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208289s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208289Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208289Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208289Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/02/2021	SUPPL-6		Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208289Orig1s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208289Orig1s006ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/208289Orig1s006.pdf
04/08/2020	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208289s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208289Orig1s005ltr.pdf
08/10/2018	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208289s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208289Orig1s002ltr.pdf

Labels for NDA 208289

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/02/2021	SUPPL-6	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208289Orig1s006lbl.pdf
04/08/2020	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208289s005lbl.pdf
08/10/2018	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208289s002lbl.pdf
04/29/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208289s000lbl.pdf

Therapeutic Equivalents for NDA 208289

AKOVAZ

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	PAR STERILE PRODUCTS
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	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 PHARMA LTD
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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