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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 207968


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NDA 207968 describes JADENU SPRINKLE, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. Additional details are available on the JADENU SPRINKLE profile page.

The generic ingredient in JADENU SPRINKLE is deferasirox. There are twenty drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the deferasirox profile page.
Summary for 207968
Tradename:JADENU SPRINKLE
Applicant:Novartis
Ingredient:deferasirox
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 207968
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
JADENU SPRINKLE deferasirox GRANULE;ORAL 207968 NDA Novartis Pharmaceuticals Corporation 0078-0713 0078-0713-15 30 PACKET in 1 CARTON (0078-0713-15) / 1 GRANULE in 1 PACKET (0078-0713-19)
JADENU SPRINKLE deferasirox GRANULE;ORAL 207968 NDA Novartis Pharmaceuticals Corporation 0078-0720 0078-0720-15 30 PACKET in 1 CARTON (0078-0720-15) / 1 GRANULE in 1 PACKET (0078-0720-19)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GRANULE;ORALStrength90MG
Approval Date:May 18, 2017TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:GRANULE;ORALStrength180MG
Approval Date:May 18, 2017TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:GRANULE;ORALStrength360MG
Approval Date:May 18, 2017TE:ABRLD:Yes

Expired US Patents for NDA 207968

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis JADENU SPRINKLE deferasirox GRANULE;ORAL 207968-001 May 18, 2017 ⤷  Try a Trial ⤷  Try a Trial
Novartis JADENU SPRINKLE deferasirox GRANULE;ORAL 207968-002 May 18, 2017 ⤷  Try a Trial ⤷  Try a Trial
Novartis JADENU SPRINKLE deferasirox GRANULE;ORAL 207968-003 May 18, 2017 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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