Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019668

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CARDURA (DOXAZOSIN MESYLATE)
EQ 1MG BASE
Marketing Status: Prescription

Active Ingredient: DOXAZOSIN MESYLATE
Proprietary Name: CARDURA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 1MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N019668
Product Number: 001
Approval Date: Nov 2, 1990
Applicant Holder Full Name: VIATRIS SPECIALTY LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

CARDURA (DOXAZOSIN MESYLATE)
EQ 2MG BASE
Marketing Status: Prescription

Active Ingredient: DOXAZOSIN MESYLATE
Proprietary Name: CARDURA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 2MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N019668
Product Number: 002
Approval Date: Nov 2, 1990
Applicant Holder Full Name: VIATRIS SPECIALTY LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

CARDURA (DOXAZOSIN MESYLATE)
EQ 4MG BASE
Marketing Status: Prescription

Active Ingredient: DOXAZOSIN MESYLATE
Proprietary Name: CARDURA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 4MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N019668
Product Number: 003
Approval Date: Nov 2, 1990
Applicant Holder Full Name: VIATRIS SPECIALTY LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

CARDURA (DOXAZOSIN MESYLATE)
EQ 8MG BASE
Marketing Status: Prescription

Active Ingredient: DOXAZOSIN MESYLATE
Proprietary Name: CARDURA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 8MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N019668
Product Number: 004
Approval Date: Nov 2, 1990
Applicant Holder Full Name: VIATRIS SPECIALTY LLC
Marketing Status:  Prescription
Patent and Exclusivity Information