Details for New Drug Application (NDA): 213976
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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
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
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: | RX | Dosage: | SUSPENSION;ORAL | Strength | 2MG/10ML | ||||
Approval Date: | Feb 9, 2024 | TE: | 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 Up | Patent Expiration: | Nov 22, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? |
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