Details for New Drug Application (NDA): 211929
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NDA 211929 describes ORTIKOS, which is a drug marketed by Sun Pharm Inds Inc and is included in one NDA. There are two patents protecting this drug. Additional details are available on the ORTIKOS profile page.
The generic ingredient in ORTIKOS 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 ORTIKOS 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 211929
| Tradename: | ORTIKOS |
| Applicant: | Sun Pharm Inds Inc |
| Ingredient: | budesonide |
| Patents: | 2 |
| Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 211929
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, DELAYED RELEASE;ORAL | Strength | 6MG | ||||
| Approval Date: | Jun 13, 2019 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Sep 9, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF MILD TO MODERATE ACTIVE CROHN'S DISEASE INVOLVING THE ILEUM AND/OR THE ASCENDING COLON | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Sep 9, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF MILD TO MODERATE ACTIVE CROHN'S DISEASE INVOLVING THE ILEUM AND/OR THE ASCENDING COLON | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, DELAYED RELEASE;ORAL | Strength | 9MG | ||||
| Approval Date: | Jun 13, 2019 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Sep 9, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF MILD TO MODERATE ACTIVE CROHN'S DISEASE INVOLVING THE ILEUM AND/OR THE ASCENDING COLON | ||||||||
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