Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 212436

Expand all

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English