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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 213976


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NDA 213976 describes EOHILIA, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from one supplier. There are twelve patents protecting this drug. Additional details are available on the EOHILIA profile page.

The generic ingredient in EOHILIA is budesonide. There are twenty-two drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the budesonide profile page.
Summary for 213976
Tradename:EOHILIA
Applicant:Takeda Pharms Usa
Ingredient:budesonide
Patents:12
Pharmacology for NDA: 213976
Medical Subject Heading (MeSH) Categories for 213976
Suppliers and Packaging for NDA: 213976
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EOHILIA budesonide SUSPENSION;ORAL 213976 NDA TAKEDA PHARMACEUTICALS AMERICA, INC. 64764-105 64764-105-00 10 POUCH in 1 CARTON (64764-105-00) / 10 mL in 1 POUCH (64764-105-01)
EOHILIA budesonide SUSPENSION;ORAL 213976 NDA TAKEDA PHARMACEUTICALS AMERICA, INC. 64764-105 64764-105-60 60 POUCH in 1 CARTON (64764-105-60) / 10 mL in 1 POUCH (64764-105-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength2MG/10ML
Approval Date:Feb 9, 2024TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 9, 2027
Regulatory Exclusivity Use:NEW PRODUCT
Regulatory Exclusivity Expiration:Feb 9, 2031
Regulatory Exclusivity Use:TREATMENT OF ADULT AND PEDIATRIC PATIENTS 11 YEARS OF AGE AND OLDER WITH EOSINOPHILIC ESOPHAGITIS (EOE)
Patent:⤷  Sign UpPatent Expiration:Nov 22, 2028Product Flag?YSubstance Flag?Delist Request?

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