Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 212436

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IBRANCE (PALBOCICLIB)
75MG
Marketing Status: Prescription

Active Ingredient: PALBOCICLIB
Proprietary Name: IBRANCE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 75MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N212436
Product Number: 001
Approval Date: Nov 1, 2019
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information

IBRANCE (PALBOCICLIB)
100MG
Marketing Status: Prescription

Active Ingredient: PALBOCICLIB
Proprietary Name: IBRANCE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N212436
Product Number: 002
Approval Date: Nov 1, 2019
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information

IBRANCE (PALBOCICLIB)
125MG
Marketing Status: Prescription

Active Ingredient: PALBOCICLIB
Proprietary Name: IBRANCE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 125MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N212436
Product Number: 003
Approval Date: Nov 1, 2019
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information