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 "019962."


Active Ingredient: METOPROLOL SUCCINATE
Dosage Form;Route: TABLET, EXTENDED RELEASE; ORAL
Proprietary Name: TOPROL-XL
Applicant: ASTRAZENECA
Strength: EQ 50MG TARTRATE
Application Number: N019962
Product Number: 001
Approval Date: Jan 10, 1992
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View
Active Ingredient: METOPROLOL SUCCINATE
Dosage Form;Route: TABLET, EXTENDED RELEASE; ORAL
Proprietary Name: TOPROL-XL
Applicant: ASTRAZENECA
Strength: EQ 100MG TARTRATE
Application Number: N019962
Product Number: 002
Approval Date: Jan 10, 1992
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View
Active Ingredient: METOPROLOL SUCCINATE
Dosage Form;Route: TABLET, EXTENDED RELEASE; ORAL
Proprietary Name: TOPROL-XL
Applicant: ASTRAZENECA
Strength: EQ 200MG TARTRATE
Application Number: N019962
Product Number: 003
Approval Date: Jan 10, 1992
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View
Active Ingredient: METOPROLOL SUCCINATE
Dosage Form;Route: TABLET, EXTENDED RELEASE; ORAL
Proprietary Name: TOPROL-XL
Applicant: ASTRAZENECA
Strength: EQ 25MG TARTRATE
Application Number: N019962
Product Number: 004
Approval Date: Feb 5, 2001
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
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 18, 2013
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