Bicalutamide

Product NDC

63672-0005

11-digit product format

636720005

Labeler code

63672

Product ID

63672-0005_65ee30e3-b0ed-4150-b590-95387ed3a991

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Bicalutamide

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Synthon Pharmaceuticals, Inc.

Application

ANDA077973

Marketing category

ANDA

Marketing start

2009-07-06

Marketing end

0000-00-00

Substance

BICALUTAMIDE

Active strength

50 mg/1

Pharmacologic classes

Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC]

NDC exclude flag

E

Listing certified through

2017-12-31

Current FDA listing

Historical FDA.report record