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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 is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the eflornithine hydrochloride profile page.

Summary for NDA: 019879

Sanofi Aventis Us
eflornithine hydrochloride

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength200MG/ML
Approval Date:Nov 28, 1990TE:RLD:No

Expired Orange Book Patents for NDA: 019879

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us
eflornithine hydrochloride
INJECTABLE;INJECTION019879-002Nov 28, 19904,399,151► subscribe
Sanofi Aventis Us
eflornithine hydrochloride
INJECTABLE;INJECTION019879-002Nov 28, 19904,413,141► subscribe
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