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 "016295."


Active Ingredient: HYDROXYUREA
Dosage Form;Route: CAPSULE; ORAL
Proprietary Name: HYDREA
Applicant: BRISTOL MYERS SQUIBB
Strength: 500MG
Application Number: N016295
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View
Active Ingredient: HYDROXYUREA
Dosage Form;Route: CAPSULE; ORAL
Proprietary Name: DROXIA
Applicant: BRISTOL MYERS SQUIBB
Strength: 200MG
Application Number: N016295
Product Number: 002
Approval Date: Feb 25, 1998
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View
Active Ingredient: HYDROXYUREA
Dosage Form;Route: CAPSULE; ORAL
Proprietary Name: DROXIA
Applicant: BRISTOL MYERS SQUIBB
Strength: 300MG
Application Number: N016295
Product Number: 003
Approval Date: Feb 25, 1998
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View
Active Ingredient: HYDROXYUREA
Dosage Form;Route: CAPSULE; ORAL
Proprietary Name: DROXIA
Applicant: BRISTOL MYERS SQUIBB
Strength: 400MG
Application Number: N016295
Product Number: 004
Approval Date: Feb 25, 1998
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
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 May, 2013
    Patent and Generic Drug Product Data Last Updated: June 19, 2013
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