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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213407
Company: NEXUS

Products on NDA 213407

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EMERPHED	EPHEDRINE SULFATE	50MG/10ML (5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP1	Yes	Yes
EMERPHED	EPHEDRINE SULFATE	25MG/5ML (5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 213407

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/17/2020	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213407s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213407Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213407Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/15/2024	SUPPL-9	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213407s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213407Orig1s009ltr.pdf
02/28/2023	SUPPL-4	Manufacturing (CMC)-Facility	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213407Orig1s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213407Orig1s004ltr.pdf

Labels for NDA 213407

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/15/2024	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213407s009lbl.pdf
08/15/2024	SUPPL-9	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213407s009lbl.pdf
02/28/2023	SUPPL-4	Manufacturing (CMC)-Facility	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213407Orig1s004lbl.pdf
04/17/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213407s000lbl.pdf

Therapeutic Equivalents for NDA 213407

EMERPHED

SOLUTION;INTRAVENOUS; 50MG/10ML (5MG/ML)
TE Code = AP1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EMERPHED	EPHEDRINE SULFATE	50MG/10ML (5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP1	213407	NEXUS
EPHEDRINE SULFATE	EPHEDRINE SULFATE	50MG/10ML (5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP1	218211	GLAND

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