Details for New Drug Application (NDA): 019879

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NDA 019879 describes ORNIDYL, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. Additional details are available on the ORNIDYL profile page.

The generic ingredient in ORNIDYL is eflornithine hydrochloride. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the eflornithine hydrochloride profile page.

Summary for 019879

Tradename:	ORNIDYL
Applicant:	Sanofi Aventis Us
Ingredient:	eflornithine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 019879

Antineoplastic Agents
Ornithine Decarboxylase Inhibitors
Trypanocidal Agents

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	200MG/ML
Approval Date:	Nov 28, 1990	TE:		RLD:	No

Expired US Patents for NDA 019879

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	ORNIDYL	eflornithine hydrochloride	INJECTABLE;INJECTION	019879-002	Nov 28, 1990	⤷ Sign Up	⤷ Sign Up
Sanofi Aventis Us	ORNIDYL	eflornithine hydrochloride	INJECTABLE;INJECTION	019879-002	Nov 28, 1990	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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