Details for New Drug Application (NDA): 203634
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NDA 203634 describes UCERIS, which is a drug marketed by Salix and is included in two NDAs. It is available from four suppliers. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the UCERIS profile page.
The generic ingredient in UCERIS 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.
The generic ingredient in UCERIS 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 203634
| Tradename: | UCERIS |
| Applicant: | Salix |
| Ingredient: | budesonide |
| Patents: | 5 |
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: | ⤷ Subscribe | Patent Expiration: | Sep 7, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Subscribe | Patent Expiration: | Sep 7, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Subscribe | 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 | ⤷ Subscribe | ⤷ Subscribe |
| Salix | UCERIS | budesonide | TABLET, EXTENDED RELEASE;ORAL | 203634-001 | Jan 14, 2013 | ⤷ Subscribe | ⤷ Subscribe |
| Salix | UCERIS | budesonide | TABLET, EXTENDED RELEASE;ORAL | 203634-001 | Jan 14, 2013 | ⤷ Subscribe | ⤷ Subscribe |
| Salix | UCERIS | budesonide | TABLET, EXTENDED RELEASE;ORAL | 203634-001 | Jan 14, 2013 | ⤷ Subscribe | ⤷ Subscribe |
| Salix | UCERIS | budesonide | TABLET, EXTENDED RELEASE;ORAL | 203634-001 | Jan 14, 2013 | ⤷ Subscribe | ⤷ Subscribe |
| Salix | UCERIS | budesonide | TABLET, EXTENDED RELEASE;ORAL | 203634-001 | Jan 14, 2013 | ⤷ Subscribe | ⤷ Subscribe |
| Salix | UCERIS | budesonide | TABLET, EXTENDED RELEASE;ORAL | 203634-001 | Jan 14, 2013 | ⤷ Subscribe | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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