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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 210045

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CONSENSI (AMLODIPINE BESYLATE; CELECOXIB)
EQ 2.5MG BASE;200MG
Marketing Status: Discontinued
Active Ingredient: AMLODIPINE BESYLATE; CELECOXIB
Proprietary Name: CONSENSI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 2.5MG BASE;200MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N210045
Product Number: 001
Approval Date: May 31, 2018
Applicant Holder Full Name: PURPLE BIOTECH LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
CONSENSI (AMLODIPINE BESYLATE; CELECOXIB)
EQ 5MG BASE;200MG
Marketing Status: Discontinued
Active Ingredient: AMLODIPINE BESYLATE; CELECOXIB
Proprietary Name: CONSENSI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE;200MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N210045
Product Number: 002
Approval Date: May 31, 2018
Applicant Holder Full Name: PURPLE BIOTECH LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
CONSENSI (AMLODIPINE BESYLATE; CELECOXIB)
EQ 10MG BASE;200MG
Marketing Status: Discontinued
Active Ingredient: AMLODIPINE BESYLATE; CELECOXIB
Proprietary Name: CONSENSI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE;200MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N210045
Product Number: 003
Approval Date: May 31, 2018
Applicant Holder Full Name: PURPLE BIOTECH LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
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