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
7b00e08c-9a1c-09e0-e053-2a91aa0a7638
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 29, 2023
Manufacturers
FDA
Yiling Pharmaceutical, Inc.
DUNS: 079417422
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Letrozole Tablets
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69117-0004
Application NumberANDA205869
Product Classification
M
Marketing Category
C73584
G
Generic Name
Letrozole Tablets
Product Specifications
Route of AdministrationORAL
Effective DateDecember 29, 2023
FDA Product Classification
INGREDIENTS (1)
LETROZOLEActive
Quantity: 2.5 mg in 1 1
Code: 7LKK855W8I
Classification: ACTIB