You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 21, 2024

Details for New Drug Application (NDA): 214010

✉ Email this page to a colleague

« Back to Dashboard

NDA 214010 describes AMPHOTERICIN B, which is a drug marketed by Eugia Pharma, Spil, Abbott, Abraxis Pharm, Teva Parenteral, and Xgen Pharms, and is included in six NDAs. It is available from three suppliers. Additional details are available on the AMPHOTERICIN B profile page.

The generic ingredient in AMPHOTERICIN B is amphotericin b. There are fifteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the amphotericin b profile page.

Summary for 214010

Tradename:	AMPHOTERICIN B
Applicant:	Eugia Pharma
Ingredient:	amphotericin b
Patents:	0

Pharmacology for NDA: 214010

Medical Subject Heading (MeSH) Categories for 214010

Amebicides
Anti-Bacterial Agents
Antifungal Agents
Antiprotozoal Agents

Suppliers and Packaging for NDA: 214010

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMPHOTERICIN B	amphotericin b	INJECTABLE, LIPOSOMAL;INJECTION	214010	ANDA	Eugia US LLC	55150-365	55150-365-01	1 VIAL, SINGLE-DOSE in 1 CARTON (55150-365-01) / 12.5 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE, LIPOSOMAL;INJECTION			Strength	50MG/VIAL
Approval Date:	Nov 17, 2022	TE:	AB	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. 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.