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Details for New Drug Application (NDA): 207103

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NDA 207103 describes IBRANCE, which is a drug marketed by Pfizer Inc and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug. Additional details are available on the IBRANCE profile page.

The generic ingredient in IBRANCE is palbociclib. Two suppliers are listed for this compound. Additional details are available on the palbociclib profile page.

Summary for NDA: 207103

Tradename:
IBRANCE
Applicant:
Pfizer Inc
Ingredient:
palbociclib
Patents:3

Pharmacology for NDA: 207103

Suppliers and Packaging for NDA: 207103

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IBRANCE
palbociclib
CAPSULE;ORAL 207103 NDA Pfizer Laboratories Div Pfizer Inc 0069-0187 0069-0187-21 21 CAPSULE in 1 BOTTLE (0069-0187-21)
IBRANCE
palbociclib
CAPSULE;ORAL 207103 NDA Pfizer Laboratories Div Pfizer Inc 0069-0188 0069-0188-21 21 CAPSULE in 1 BOTTLE (0069-0188-21)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength75MG
Approval Date:Feb 3, 2015TE:RLD:No
Patent:6,936,612Patent Expiration:Jan 22, 2023Product Flag?YSubstance Flag?YDelist Request?
Patent:7,208,489Patent Expiration:Jan 16, 2023Product Flag?YSubstance Flag?YDelist Request?
Regulatory Exclusivity Expiration:Feb 3, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY


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