Details for New Drug Application (NDA): 205457
✉ Email this page to a colleague
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 205457
Tradename: | BUDESONIDE |
Applicant: | Actavis Labs Fl Inc |
Ingredient: | budesonide |
Patents: | 0 |
Pharmacology for NDA: 205457
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 205457
Suppliers and Packaging for NDA: 205457
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BUDESONIDE | budesonide | TABLET, EXTENDED RELEASE;ORAL | 205457 | ANDA | Actavis Pharma, Inc. | 0591-2510 | 0591-2510-30 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0591-2510-30) |
BUDESONIDE | budesonide | TABLET, EXTENDED RELEASE;ORAL | 205457 | ANDA | Golden State Medical Supply, Inc. | 51407-824 | 51407-824-30 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (51407-824-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 9MG | ||||
Approval Date: | Jul 3, 2018 | TE: | AB | RLD: | No |
Complete Access Available with Subscription