Erlotinib Hydrochloride

Product NDC

42292-051

11-digit product format

422920051

Labeler code

42292

Product ID

42292-051_b4dc994e-d507-2fc0-e053-2a95a90ae131

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

erlotinib hydrochloride

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Mylan Institutional Inc.

Application

ANDA091002

Marketing category

ANDA

Marketing start

2019-05-28

Marketing end

2021-01-31

Substance

ERLOTINIB

Active strength

25 mg/1

Pharmacologic classes

Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record