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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 210807

DELSTRIGO (DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE)
100MG;300MG;300MG
Marketing Status: Prescription
Active Ingredient: DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
Proprietary Name: DELSTRIGO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG;300MG;300MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N210807
Product Number: 001
Approval Date: Aug 30, 2018
Applicant Holder Full Name: MERCK SHARP AND DOHME CORP A SUB OF MERCK AND CO INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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