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-one suppliers are listed for this compound. Additional details are available on the budesonide profile page.
The generic ingredient in EOHILIA is budesonide. There are twenty-two drug master file entries for this compound. Forty-one 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: | 10,293,052 | Patent Expiration: | Nov 22, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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