Toremifene Citrate
These highlights do not include all the information needed to use TOREMIFENE CITRATE TABLETS safely and effectively. See full prescribing information for TOREMIFENE CITRATE TABLETS. TOREMIFENE CITRATE tablets, for oral administrationInitial U.S. Approval: 1997
Approved
Approval ID
dbde10d5-c689-428f-841d-b34aa5addf2d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 4, 2019
Manufacturers
FDA
Rising Pharma Holdings, inc.
DUNS: 116880195
FDA
Rising Pharma Holdings, Inc.
DUNS: 116880195
FDA
Rising Pharmaceuticals, Inc.
DUNS: 041241766
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Toremifene Citrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64980-404
Application NumberANDA208813
Product Classification
M
Marketing Category
C73584
G
Generic Name
Toremifene Citrate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 4, 2019
FDA Product Classification
INGREDIENTS (7)
toremifene citrateActive
Quantity: 60 mg in 1 1
Code: 2498Y783QT
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
COPOVIDONEInactive
Code: D9C330MD8B
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT