Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 201966

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BUDESONIDE (BUDESONIDE)
0.25MG/2ML
Marketing Status: Prescription

Active Ingredient: BUDESONIDE
Proprietary Name: BUDESONIDE
Dosage Form; Route of Administration: SUSPENSION; INHALATION
Strength: 0.25MG/2ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AN
Application Number: A201966
Product Number: 003
Approval Date: Sep 27, 2013
Applicant Holder Full Name: SANDOZ INC
Marketing Status:  Prescription
Patent and Exclusivity Information

BUDESONIDE (BUDESONIDE)
0.5MG/2ML
Marketing Status: Prescription

Active Ingredient: BUDESONIDE
Proprietary Name: BUDESONIDE
Dosage Form; Route of Administration: SUSPENSION; INHALATION
Strength: 0.5MG/2ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AN
Application Number: A201966
Product Number: 002
Approval Date: Sep 27, 2013
Applicant Holder Full Name: SANDOZ INC
Marketing Status:  Prescription
Patent and Exclusivity Information

BUDESONIDE (BUDESONIDE)
1MG/2ML
Marketing Status: Prescription

Active Ingredient: BUDESONIDE
Proprietary Name: BUDESONIDE
Dosage Form; Route of Administration: SUSPENSION; INHALATION
Strength: 1MG/2ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AN
Application Number: A201966
Product Number: 001
Approval Date: Sep 27, 2013
Applicant Holder Full Name: SANDOZ INC
Marketing Status:  Prescription
Patent and Exclusivity Information