U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Orange Book Home

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 019962

Expand all

TOPROL-XL (METOPROLOL SUCCINATE)
EQ 25MG TARTRATE
Marketing Status: Prescription
Active Ingredient: METOPROLOL SUCCINATE
Proprietary Name: TOPROL-XL
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 25MG TARTRATE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N019962
Product Number: 004
Approval Date: Feb 5, 2001
Applicant Holder Full Name: TOPROL ACQUISITION LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
TOPROL-XL (METOPROLOL SUCCINATE)
EQ 50MG TARTRATE
Marketing Status: Prescription
Active Ingredient: METOPROLOL SUCCINATE
Proprietary Name: TOPROL-XL
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 50MG TARTRATE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N019962
Product Number: 001
Approval Date: Jan 10, 1992
Applicant Holder Full Name: TOPROL ACQUISITION LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
TOPROL-XL (METOPROLOL SUCCINATE)
EQ 100MG TARTRATE
Marketing Status: Prescription
Active Ingredient: METOPROLOL SUCCINATE
Proprietary Name: TOPROL-XL
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 100MG TARTRATE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N019962
Product Number: 002
Approval Date: Jan 10, 1992
Applicant Holder Full Name: TOPROL ACQUISITION LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
TOPROL-XL (METOPROLOL SUCCINATE)
EQ 200MG TARTRATE
Marketing Status: Prescription
Active Ingredient: METOPROLOL SUCCINATE
Proprietary Name: TOPROL-XL
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 200MG TARTRATE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N019962
Product Number: 003
Approval Date: Jan 10, 1992
Applicant Holder Full Name: TOPROL ACQUISITION LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top