Details for New Drug Application (NDA): 206134
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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 206134
Tradename: | BUDESONIDE |
Applicant: | Zydus Pharms |
Ingredient: | budesonide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 206134
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 206134
Suppliers and Packaging for NDA: 206134
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BUDESONIDE | budesonide | CAPSULE, DELAYED RELEASE;ORAL | 206134 | ANDA | Northstar Rx LLC. | 16714-829 | 16714-829-01 | 100 CAPSULE, COATED PELLETS in 1 BOTTLE (16714-829-01) |
BUDESONIDE | budesonide | CAPSULE, DELAYED RELEASE;ORAL | 206134 | ANDA | American Health Packaging | 60687-596 | 60687-596-32 | 20 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-596-32) / 1 CAPSULE, COATED PELLETS in 1 BLISTER PACK (60687-596-33) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED RELEASE;ORAL | Strength | 3MG | ||||
Approval Date: | May 4, 2017 | TE: | AB | RLD: | No |
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