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 administration Initial U.S. Approval: [1997]
Approved
Approval ID
0b3ebaa6-9cbe-405e-8f14-14ce8dcd2a68
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 20, 2020
Manufacturers
FDA
MSN LABORATORIES PRIVATE LIMITED
DUNS: 650786952
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 Code69539-152
Application NumberANDA212818
Product Classification
M
Marketing Category
C73584
G
Generic Name
toremifene citrate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 20, 2020
FDA Product Classification
INGREDIENTS (8)
TOREMIFENE CITRATEActive
Quantity: 60 mg in 1 1
Code: 2498Y783QT
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT