Details for New Drug Application (NDA): 216667
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The generic ingredient in BUDESONIDE 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 216667
Tradename: | BUDESONIDE |
Applicant: | Eugia Pharma |
Ingredient: | budesonide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 216667
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 216667
Suppliers and Packaging for NDA: 216667
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BUDESONIDE | budesonide | SUSPENSION;INHALATION | 216667 | ANDA | Aurobindo Pharma Limited | 59651-585 | 59651-585-30 | 6 POUCH in 1 CARTON (59651-585-30) / 5 AMPULE in 1 POUCH (59651-585-05) / 2 mL in 1 AMPULE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;INHALATION | Strength | 0.5MG/2ML | ||||
Approval Date: | Nov 29, 2023 | TE: | AN | RLD: | No |
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