Details for New Drug Application (NDA): 215328
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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 215328
Tradename: | BUDESONIDE |
Applicant: | Padagis Israel |
Ingredient: | budesonide |
Patents: | 0 |
Pharmacology for NDA: 215328
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 215328
Suppliers and Packaging for NDA: 215328
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BUDESONIDE | budesonide | AEROSOL, FOAM;RECTAL | 215328 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-627 | 45802-627-86 | 2 CANISTER in 1 CARTON (45802-627-86) / 1 AEROSOL, FOAM in 1 CANISTER (45802-627-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | AEROSOL, FOAM;RECTAL | Strength | 2MG/ACTUATION | ||||
Approval Date: | Apr 12, 2023 | TE: | AB | RLD: | No |
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