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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 203045

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ISENTRESS (RALTEGRAVIR POTASSIUM)
EQ 25MG BASE
Marketing Status: Prescription
Active Ingredient: RALTEGRAVIR POTASSIUM
Proprietary Name: ISENTRESS
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: EQ 25MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N203045
Product Number: 001
Approval Date: Dec 21, 2011
Applicant Holder Full Name: MERCK SHARP AND DOHME LLC A SUB OF MERCK AND CO INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ISENTRESS (RALTEGRAVIR POTASSIUM)
EQ 100MG BASE
Marketing Status: Prescription
Active Ingredient: RALTEGRAVIR POTASSIUM
Proprietary Name: ISENTRESS
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: EQ 100MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N203045
Product Number: 002
Approval Date: Dec 21, 2011
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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