Details for New Drug Application (NDA): 210897
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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 210897
Tradename: | BUDESONIDE |
Applicant: | Lupin |
Ingredient: | budesonide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 210897
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 210897
Suppliers and Packaging for NDA: 210897
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BUDESONIDE | budesonide | SUSPENSION;INHALATION | 210897 | ANDA | A-S Medication Solutions | 50090-7126 | 50090-7126-0 | 6 POUCH in 1 CARTON (50090-7126-0) / 10 mL in 1 POUCH |
BUDESONIDE | budesonide | SUSPENSION;INHALATION | 210897 | ANDA | American Health Packaging | 60687-524 | 60687-524-83 | 30 POUCH in 1 CARTON (60687-524-83) / 1 AMPULE in 1 POUCH (60687-524-79) / 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 9, 2018 | TE: | AN | RLD: | No |
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