SOLTAMOX
These highlights do not include all the information needed to use SOLTAMOX safely and effectively. See full prescribing information for SOLTAMOX. SOLTAMOX (tamoxifen citrate) oral solution Initial U.S. Approval: 1977
Approved
Approval ID
1e6ff055-590c-41e6-9530-1fdf04cdbd02
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 29, 2021
Manufacturers
FDA
Mayne Pharma
DUNS: 867220261
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
TAMOXIFEN CITRATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51862-682
Application NumberNDA021807
Product Classification
M
Marketing Category
C73594
G
Generic Name
TAMOXIFEN CITRATE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 31, 2020
FDA Product Classification
INGREDIENTS (8)
TAMOXIFEN CITRATEActive
Quantity: 20 mg in 10 mL
Code: 7FRV7310N6
Classification: ACTIM
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
LICORICEInactive
Code: 61ZBX54883
Classification: IACT
ANISEInactive
Code: 21C2F5E8RE
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT