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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 209571

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DARIFENACIN HYDROBROMIDE (DARIFENACIN HYDROBROMIDE)
EQ 7.5MG BASE
Marketing Status: Discontinued
Active Ingredient: DARIFENACIN HYDROBROMIDE
Proprietary Name: DARIFENACIN HYDROBROMIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 7.5MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A209571
Product Number: 002
Approval Date: Oct 22, 2019
Applicant Holder Full Name: XIROMED PHARMA ESPANA SL
Marketing Status:  Discontinued
Patent and Exclusivity Information
DARIFENACIN HYDROBROMIDE (DARIFENACIN HYDROBROMIDE)
EQ 15MG BASE
Marketing Status: Discontinued
Active Ingredient: DARIFENACIN HYDROBROMIDE
Proprietary Name: DARIFENACIN HYDROBROMIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 15MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A209571
Product Number: 001
Approval Date: Oct 22, 2019
Applicant Holder Full Name: XIROMED PHARMA ESPANA SL
Marketing Status:  Discontinued
Patent and Exclusivity Information
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