Aromasin
Approved
Approval ID
f0b31daa-0792-43d5-af08-8b6a864dc90a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 4, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
exemestane
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5261
Application NumberNDA020753
Product Classification
M
Marketing Category
C73594
G
Generic Name
exemestane
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 4, 2010
FDA Product Classification
INGREDIENTS (15)
EXEMESTANEActive
Quantity: 25 mg in 1 1
Code: NY22HMQ4BX
Classification: ACTIB
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
MAGNESIUM CARBONATEInactive
Code: 0E53J927NA
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT