Details for New Drug Application (NDA): 203634
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The generic ingredient in UCERIS 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 203634
Tradename: | UCERIS |
Applicant: | Salix |
Ingredient: | budesonide |
Patents: | 5 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 203634
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 203634
Suppliers and Packaging for NDA: 203634
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
UCERIS | budesonide | TABLET, EXTENDED RELEASE;ORAL | 203634 | NDA AUTHORIZED GENERIC | Bryant Ranch Prepack | 63629-9093 | 63629-9093-1 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-9093-1) |
UCERIS | budesonide | TABLET, EXTENDED RELEASE;ORAL | 203634 | NDA | Santarus Inc. | 68012-309 | 68012-309-01 | 2 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68012-309-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 9MG | ||||
Approval Date: | Jan 14, 2013 | TE: | AB | RLD: | Yes | ||||
Patent: | ⤷ Sign Up | Patent Expiration: | Sep 7, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Sep 7, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Sep 7, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? |
Expired US Patents for NDA 203634
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Salix | UCERIS | budesonide | TABLET, EXTENDED RELEASE;ORAL | 203634-001 | Jan 14, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Salix | UCERIS | budesonide | TABLET, EXTENDED RELEASE;ORAL | 203634-001 | Jan 14, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Salix | UCERIS | budesonide | TABLET, EXTENDED RELEASE;ORAL | 203634-001 | Jan 14, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Salix | UCERIS | budesonide | TABLET, EXTENDED RELEASE;ORAL | 203634-001 | Jan 14, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Salix | UCERIS | budesonide | TABLET, EXTENDED RELEASE;ORAL | 203634-001 | Jan 14, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Salix | UCERIS | budesonide | TABLET, EXTENDED RELEASE;ORAL | 203634-001 | Jan 14, 2013 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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