LETROZOLE
Letrozole Tablets, USP Rx only These highlights do not include all the information needed to use LETROZOLE TABLETS safely and effectively. See full prescribing information for LETROZOLE TABLETS. Initial U.S. Approval: 1997
Approved
Approval ID
93f317f1-96d1-498e-e053-2995a90ac60d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2024
Manufacturers
FDA
AvPAK
DUNS: 832926666
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 Code50268-476
Application NumberANDA200161
Product Classification
M
Marketing Category
C73584
G
Generic Name
LETROZOLE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 9, 2024
FDA Product Classification
INGREDIENTS (12)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
LETROZOLEActive
Quantity: 2.5 mg in 1 1
Code: 7LKK855W8I
Classification: ACTIB