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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 211929

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ORTIKOS (BUDESONIDE)
6MG
Marketing Status: Discontinued
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
ORTIKOS (BUDESONIDE)
9MG
Marketing Status: Discontinued
Active Ingredient: BUDESONIDE
Proprietary Name: ORTIKOS
Dosage Form; Route of Administration: CAPSULE, DELAYED RELEASE; ORAL
Strength: 9MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N211929
Product Number: 002
Approval Date: Jun 13, 2019
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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