Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
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U.S. Department of Health and Human Services

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Search results from the "OB_Rx" table for query on "020929."



Active Ingredient: BUDESONIDE
Dosage Form;Route: SUSPENSION;INHALATION
Proprietary Name: PULMICORT RESPULES
Applicant: ASTRAZENECA
Strength: 0.25MG/2ML
Application Number: N020929
Product Number: 001
Approval Date: Aug 8, 2000
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AN
Patent and Exclusivity Info for this product: View

Active Ingredient: BUDESONIDE
Dosage Form;Route: SUSPENSION;INHALATION
Proprietary Name: PULMICORT RESPULES
Applicant: ASTRAZENECA
Strength: 0.5MG/2ML
Application Number: N020929
Product Number: 002
Approval Date: Aug 8, 2000
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AN
Patent and Exclusivity Info for this product: View

Active Ingredient: BUDESONIDE
Dosage Form;Route: SUSPENSION;INHALATION
Proprietary Name: PULMICORT RESPULES
Applicant: ASTRAZENECA
Strength: 1MG/2ML
Application Number: N020929
Product Number: 003
Approval Date: Aug 8, 2000
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code: AN
Patent and Exclusivity Info for this product: View

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FDA/Center for Drug Evaluation and Research
Office of Generic Drugs
Division of Labeling and Program Support
Update Frequency:

Orange Book Data - Monthly
Generic Drug Product Information & Patent Information - Daily
Orange Book Data Updated Through March 01, 2014
Patent and Generic Drug Product Data Last Updated April 18, 2014

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