Bicalutamide

Product NDC

16714-571

11-digit product format

167140571

Labeler code

16714

Product ID

16714-571_963fe7a5-8c45-4071-8017-96f033a17d48

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

bicalutamide

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Northstar RxLLC

Application

ANDA078634

Marketing category

ANDA

Marketing start

2009-08-28

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

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record