Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 219423

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WIDAPLIK (AMLODIPINE BESYLATE; INDAPAMIDE; TELMISARTAN)
EQ 1.25MG BASE;0.625MG;10MG
Marketing Status: Prescription

Active Ingredient: AMLODIPINE BESYLATE; INDAPAMIDE; TELMISARTAN
Proprietary Name: WIDAPLIK
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 1.25MG BASE;0.625MG;10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N219423
Product Number: 001
Approval Date: Jun 5, 2025
Applicant Holder Full Name: AZURITY PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

WIDAPLIK (AMLODIPINE BESYLATE; INDAPAMIDE; TELMISARTAN)
EQ 2.5MG BASE;1.25MG;20MG
Marketing Status: Prescription

Active Ingredient: AMLODIPINE BESYLATE; INDAPAMIDE; TELMISARTAN
Proprietary Name: WIDAPLIK
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 2.5MG BASE;1.25MG;20MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N219423
Product Number: 002
Approval Date: Jun 5, 2025
Applicant Holder Full Name: AZURITY PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

WIDAPLIK (AMLODIPINE BESYLATE; INDAPAMIDE; TELMISARTAN)
EQ 5MG BASE;2.5MG;40MG
Marketing Status: Prescription

Active Ingredient: AMLODIPINE BESYLATE; INDAPAMIDE; TELMISARTAN
Proprietary Name: WIDAPLIK
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE;2.5MG;40MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N219423
Product Number: 003
Approval Date: Jun 5, 2025
Applicant Holder Full Name: AZURITY PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information