Active Ingredient: BUDESONIDE
Proprietary Name: ORTIKOS
Dosage Form; Route of Administration: CAPSULE, DELAYED RELEASE; ORAL
Strength: 6MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N211929
Product Number: 001
Approval Date: Jun 13, 2019
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES INC
Marketing Status:
Discontinued
Patent and Exclusivity Information