Details for New Drug Application (NDA): 020038

✉ Email this page to a colleague

NDA 020038 describes FLUDARA, which is a drug marketed by Genzyme Corp, Actavis Llc, Actavis Totowa, Areva Pharms, Extrovis, Fresenius Kabi Usa, Hikma, Hospira, Rising, Sagent Pharms Inc, and Sandoz, and is included in twelve NDAs. Additional details are available on the FLUDARA profile page.

The generic ingredient in FLUDARA is fludarabine phosphate. There are ten drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the fludarabine phosphate profile page.

Summary for 020038

Tradename:	FLUDARA
Applicant:	Genzyme Corp
Ingredient:	fludarabine phosphate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Apr 18, 1991	TE:		RLD:	Yes

Expired US Patents for NDA 020038

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Genzyme Corp	FLUDARA	fludarabine phosphate	INJECTABLE;INJECTION	020038-001	Apr 18, 1991	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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.