Letrozole
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
35c73219-c39e-4e10-b944-76009b061e79
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 5, 2020
Manufacturers
FDA
Natco Pharma Limited
DUNS: 650224736
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 Code63850-0025
Application NumberANDA200161
Product Classification
M
Marketing Category
C73584
G
Generic Name
Letrozole
Product Specifications
Route of AdministrationORAL
Effective DateOctober 21, 2020
FDA Product Classification
INGREDIENTS (12)
LETROZOLEActive
Quantity: 2.5 mg in 1 1
Code: 7LKK855W8I
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT