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Details for New Drug Application (NDA): 205858

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NDA 205858 describes ZYDELIG, which is a drug marketed by Gilead Sciences Inc and is included in one NDA. It is available from one supplier. There are ten patents protecting this drug. Additional details are available on the ZYDELIG profile page.

The generic ingredient in ZYDELIG is idelalisib. One supplier is listed for this compound. Additional details are available on the idelalisib profile page.

Summary for NDA: 205858

Tradename:
ZYDELIG
Applicant:
Gilead Sciences Inc
Ingredient:
idelalisib
Patents:10

Pharmacology for NDA: 205858

Suppliers and Packaging for NDA: 205858

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZYDELIG
idelalisib
TABLET;ORAL 205858 NDA Gilead Sciences, Inc. 61958-1701 61958-1701-1 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-1701-1)
ZYDELIG
idelalisib
TABLET;ORAL 205858 NDA Gilead Sciences, Inc. 61958-1702 61958-1702-1 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-1702-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Jul 23, 2014TE:RLD:No
Patent:8,492,389Patent Expiration:Apr 24, 2021Product Flag?YSubstance Flag?YDelist Request?
Patent:8,637,533Patent Expiration:Apr 24, 2021Product Flag?YSubstance Flag?YDelist Request?
Patent:RE44638Patent Expiration:Aug 5, 2025Product Flag?YSubstance Flag?YDelist Request?


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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 verifification 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.

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