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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021929

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SYMBICORT (BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE)
0.08MG/INH;0.0045MG/INH
Marketing Status: Prescription
Active Ingredient: BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE
Proprietary Name: SYMBICORT
Dosage Form; Route of Administration: AEROSOL, METERED; INHALATION
Strength: 0.08MG/INH;0.0045MG/INH
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021929
Product Number: 001
Approval Date: Jul 21, 2006
Applicant Holder Full Name: ASTRAZENECA LP
Marketing Status:  Prescription
Patent and Exclusivity Information
SYMBICORT (BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE)
0.16MG/INH;0.0045MG/INH
Marketing Status: Prescription
Active Ingredient: BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE
Proprietary Name: SYMBICORT
Dosage Form; Route of Administration: AEROSOL, METERED; INHALATION
Strength: 0.16MG/INH;0.0045MG/INH
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021929
Product Number: 002
Approval Date: Jul 21, 2006
Applicant Holder Full Name: ASTRAZENECA LP
Marketing Status:  Prescription
Patent and Exclusivity Information
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