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 useInitial U.S. Approval: 1997
Approved
Approval ID
8ebda73d-82a3-4b17-8a81-a1f258003d32
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 1, 2020
Manufacturers
FDA
Teva Pharmaceuticals USA, Inc.
DUNS: 001627975
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 Code0093-7620
Application NumberANDA090289
Product Classification
M
Marketing Category
C73584
G
Generic Name
Letrozole
Product Specifications
Route of AdministrationORAL
Effective DateNovember 1, 2020
FDA Product Classification
INGREDIENTS (16)
LETROZOLEActive
Quantity: 2.5 mg in 1 1
Code: 7LKK855W8I
Classification: ACTIB
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
INDIGOTINDISULFONATE SODIUMInactive
Code: D3741U8K7L
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT