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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022145

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ISENTRESS (RALTEGRAVIR POTASSIUM)
EQ 400MG BASE
Marketing Status: Prescription
Active Ingredient: RALTEGRAVIR POTASSIUM
Proprietary Name: ISENTRESS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 400MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022145
Product Number: 001
Approval Date: Oct 12, 2007
Applicant Holder Full Name: MERCK SHARP AND DOHME LLC A SUB OF MERCK AND CO INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ISENTRESS HD (RALTEGRAVIR POTASSIUM)
EQ 600MG BASE
Marketing Status: Prescription
Active Ingredient: RALTEGRAVIR POTASSIUM
Proprietary Name: ISENTRESS HD
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 600MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022145
Product Number: 002
Approval Date: May 26, 2017
Applicant Holder Full Name: MERCK SHARP AND DOHME LLC A SUB OF MERCK AND CO INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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