Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 210868

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LORBRENA (LORLATINIB)
25MG
Marketing Status: Prescription

Active Ingredient: LORLATINIB
Proprietary Name: LORBRENA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N210868
Product Number: 001
Approval Date: Nov 2, 2018
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information

LORBRENA (LORLATINIB)
100MG
Marketing Status: Prescription

Active Ingredient: LORLATINIB
Proprietary Name: LORBRENA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N210868
Product Number: 002
Approval Date: Nov 2, 2018
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information