letrozole

Product NDC

68382-363

11-digit product format

683820363

Labeler code

68382

Product ID

68382-363_a7dfded8-37bd-4d82-afff-2065e6ba24a8

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

letrozole

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Zydus Pharmaceuticals (USA) Inc.

Application

ANDA090405

Marketing category

ANDA

Marketing start

2011-06-03

Marketing end

0000-00-00

Substance

LETROZOLE

Active strength

3 mg/1

Pharmacologic classes

Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA]

NDC exclude flag

E

Listing certified through

2017-12-31

Current FDA listing

Historical FDA.report record