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LETROZOLE

Letrozole Tablets These highlights do not include all the information needed to use LETROZOLE TABLETS safely and effectively. See full prescribing information for LETROZOLE TABLETS. LETROZOLE tablets, for oral use Initial U.S. Approval: 1997

Approved
Approval ID

fa2d40a5-3504-44ef-8f5c-aa4c06308074

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 11, 2023

Manufacturers
FDA

Chartwell RX, LLC

DUNS: 079394054

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Letrozole

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code62135-491
Application NumberANDA205869
Product Classification
M
Marketing Category
C73584
G
Generic Name
Letrozole
Product Specifications
Route of AdministrationORAL
Effective DateOctober 11, 2023
FDA Product Classification

INGREDIENTS (1)

LETROZOLEActive
Quantity: 2.5 mg in 1 1
Code: 7LKK855W8I
Classification: ACTIB

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LETROZOLE - FDA Drug Approval Details