Last Updated: June 24, 2026

Details for New Drug Application (NDA): 219991

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NDA 219991 describes EPHEDRINE SULFATE, which is a drug marketed by Amneal, Caplin, Civica, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Gland, Hikma, Mankind Pharma, Ph Health, Renew Pharms, Sagent Pharms Inc, Sandoz, Xiromed, and Zydus Pharms, and is included in nineteen NDAs. It is available from nineteen suppliers. There are two patents protecting this drug. Additional details are available on the EPHEDRINE SULFATE profile page.

The generic ingredient in EPHEDRINE SULFATE is ephedrine sulfate. There are sixty-eight drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the ephedrine sulfate profile page.

Summary for 219991

Tradename:	EPHEDRINE SULFATE
Applicant:	Fresenius Kabi Usa
Ingredient:	ephedrine sulfate
Patents:	0

Medical Subject Heading (MeSH) Categories for 219991

Adrenergic Agents
Central Nervous System Stimulants
Sympathomimetics
Vasoconstrictor Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	50MG/10ML (5MG/ML)
Approval Date:	Mar 19, 2026	TE:	AP2	RLD:	No

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