MEGACE ES
These highlights do not include all the information needed to use Megace® ES safely and effectively. See full prescribing information for Megace® ES. Megace ES (megestrol acetate) Oral Suspension Initial U.S. Approval: 1993
Approved
Approval ID
e3e96f8d-31a6-4457-8e05-02579b539b8a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 30, 2011
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.
megesterol acetate
PRODUCT DETAILS
NDC Product Code54868-5572
Application NumberNDA021778
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateMarch 30, 2011
Generic Namemegesterol acetate
INGREDIENTS (9)
SUCROSEInactive
Code: C151H8M554
Classification: IACT
MEGESTROL ACETATEActive
Quantity: 125 mg in 1 mL
Code: TJ2M0FR8ES
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT