Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 217188

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PAXLOVID (COPACKAGED) (NIRMATRELVIR; RITONAVIR)
150MG;100MG
Marketing Status: Prescription

Active Ingredient: NIRMATRELVIR; RITONAVIR
Proprietary Name: PAXLOVID (COPACKAGED)
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 150MG;100MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N217188
Product Number: 001
Approval Date: May 25, 2023
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information

PAXLOVID (COPACKAGED) (NIRMATRELVIR; RITONAVIR)
300MG;100MG
Marketing Status: Prescription

Active Ingredient: NIRMATRELVIR; RITONAVIR
Proprietary Name: PAXLOVID (COPACKAGED)
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 300MG;100MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N217188
Product Number: 002
Approval Date: May 25, 2023
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information