Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 207302

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DARIFENACIN (DARIFENACIN HYDROBROMIDE)
EQ 7.5MG BASE
Marketing Status: Prescription
Active Ingredient: DARIFENACIN HYDROBROMIDE
Proprietary Name: DARIFENACIN
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 7.5MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A207302
Product Number: 001
Approval Date: Jul 28, 2017
Applicant Holder Full Name: MACLEODS PHARMACEUTICALS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
DARIFENACIN (DARIFENACIN HYDROBROMIDE)
EQ 15MG BASE
Marketing Status: Prescription
Active Ingredient: DARIFENACIN HYDROBROMIDE
Proprietary Name: DARIFENACIN
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 15MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A207302
Product Number: 002
Approval Date: Jul 28, 2017
Applicant Holder Full Name: MACLEODS PHARMACEUTICALS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

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