Details for New Drug Application (NDA): 206200
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The generic ingredient in BUDESONIDE is budesonide. There are twenty-two drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the budesonide profile page.
Summary for 206200
Tradename: | BUDESONIDE |
Applicant: | Amneal Pharms |
Ingredient: | budesonide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 206200
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 206200
Suppliers and Packaging for NDA: 206200
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BUDESONIDE | budesonide | CAPSULE, DELAYED RELEASE;ORAL | 206200 | ANDA | Major Pharmaceuticals | 0904-7166 | 0904-7166-10 | 20 BLISTER PACK in 1 CARTON (0904-7166-10) / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK |
BUDESONIDE | budesonide | CAPSULE, DELAYED RELEASE;ORAL | 206200 | ANDA | Amneal Pharmaceuticals LLC | 65162-778 | 65162-778-10 | 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65162-778-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED RELEASE;ORAL | Strength | 3MG | ||||
Approval Date: | Jul 31, 2017 | TE: | AB | RLD: | No |
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