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FDA Approval

Aromasin

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
January 4, 2010
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Exemestane(25 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Physicians Total Care, Inc.

Physicians Total Care, Inc.

194123980

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Aromasin

Product Details

NDC Product Code
54868-5261
Application Number
NDA020753
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
January 4, 2010
Code: NY22HMQ4BXClass: ACTIBQuantity: 25 mg in 1 1
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WOClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WEClass: IACT
MAGNESIUM CARBONATEInactive
Code: 0E53J927NAClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990Class: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
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