Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 021929

Expand all

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: 
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: 
Application Number: N021929
Product Number: 002
Approval Date: Jul 21, 2006
Applicant Holder Full Name: ASTRAZENECA LP
Marketing Status:  Prescription
Patent and Exclusivity Information

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English