Details for New Drug Application (NDA): 078949
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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 078949
Tradename: | BUDESONIDE |
Applicant: | Apotex Inc |
Ingredient: | budesonide |
Patents: | 0 |
Pharmacology for NDA: 078949
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 078949
Suppliers and Packaging for NDA: 078949
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BUDESONIDE | budesonide | SPRAY, METERED;NASAL | 078949 | ANDA | Walgreens | 0363-0048 | 0363-0048-01 | 1 BOTTLE, SPRAY in 1 BOTTLE, SPRAY (0363-0048-01) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY |
BUDESONIDE | budesonide | SPRAY, METERED;NASAL | 078949 | ANDA | Rugby Laboratories | 0536-1112 | 0536-1112-40 | 1 BOTTLE, SPRAY in 1 CARTON (0536-1112-40) / 60 SPRAY, METERED in 1 BOTTLE, SPRAY |
Profile for product number 002
Active Rx/OTC/Discontinued: | OTC | Dosage: | SPRAY, METERED;NASAL | Strength | 0.032MG/SPRAY | ||||
Approval Date: | Nov 20, 2015 | TE: | RLD: | No |
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