Details for New Drug Application (NDA): 212436
✉ Email this page to a colleague
The generic ingredient in IBRANCE is palbociclib. There are thirteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the palbociclib profile page.
Summary for 212436
Tradename: | IBRANCE |
Applicant: | Pfizer |
Ingredient: | palbociclib |
Patents: | 3 |
Pharmacology for NDA: 212436
Mechanism of Action | Cytochrome P450 3A Inhibitors Kinase Inhibitors |
Suppliers and Packaging for NDA: 212436
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
IBRANCE | palbociclib | TABLET;ORAL | 212436 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-0284 | 0069-0284-03 | 3 DOSE PACK in 1 CARTON (0069-0284-03) / 7 TABLET, FILM COATED in 1 DOSE PACK (0069-0284-07) |
IBRANCE | palbociclib | TABLET;ORAL | 212436 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-0486 | 0069-0486-03 | 3 DOSE PACK in 1 CARTON (0069-0486-03) / 7 TABLET, FILM COATED in 1 DOSE PACK (0069-0486-07) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 75MG | ||||
Approval Date: | Nov 1, 2019 | TE: | AB | RLD: | Yes | ||||
Patent: | ⤷ Sign Up | Patent Expiration: | Feb 8, 2034 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patent: | ⤷ Sign Up | Patent Expiration: | Aug 19, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 5, 2027 | Product Flag? | Y | Substance Flag? | Y | Delist Request? |
Expired US Patents for NDA 212436
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Pfizer | IBRANCE | palbociclib | TABLET;ORAL | 212436-002 | Nov 1, 2019 | ⤷ Sign Up | ⤷ Sign Up |
Pfizer | IBRANCE | palbociclib | TABLET;ORAL | 212436-003 | Nov 1, 2019 | ⤷ Sign Up | ⤷ Sign Up |
Pfizer | IBRANCE | palbociclib | TABLET;ORAL | 212436-001 | Nov 1, 2019 | ⤷ Sign Up | ⤷ Sign Up |
Pfizer | IBRANCE | palbociclib | TABLET;ORAL | 212436-002 | Nov 1, 2019 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Complete Access Available with Subscription