You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 12, 2025

Details for New Drug Application (NDA): 214334

✉ Email this page to a colleague

« Back to Dashboard

NDA 214334 describes EPHEDRINE SULFATE, which is a drug marketed by Amneal, Caplin, 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 seventeen 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 214334

Tradename:	EPHEDRINE SULFATE
Applicant:	Hikma
Ingredient:	ephedrine sulfate
Patents:	0

Pharmacology for NDA: 214334

Mechanism of Action	Adrenergic alpha-Agonists Adrenergic beta-Agonists
Physiological Effect	Increased Norepinephrine Activity

Medical Subject Heading (MeSH) Categories for 214334

Adrenergic Agents
Central Nervous System Stimulants
Sympathomimetics
Vasoconstrictor Agents

Suppliers and Packaging for NDA: 214334

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EPHEDRINE SULFATE	ephedrine sulfate	SOLUTION;INTRAVENOUS	214334	ANDA	Hikma Pharmaceuticals USA Inc.	0641-6238	0641-6238-25	25 VIAL, SINGLE-DOSE in 1 CARTON (0641-6238-25) / 1 mL in 1 VIAL, SINGLE-DOSE (0641-6238-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	50MG/ML (50MG/ML)
Approval Date:	Dec 15, 2020	TE:	AP	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.