MedPath

Megestrol Acetate

MEGESTROL ACETATEORAL SUSPENSION, USP40 mg/mL

Approved
Approval ID

eea3f3e0-ca3a-4f5d-8185-d52944b67e7a

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 10, 2020

Manufacturers
FDA

Morton Grove Pharmaceuticals, Inc.

DUNS: 801897505

Products 1

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

megestrol acetate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code60432-126
Application NumberANDA076721
Product Classification
M
Marketing Category
C73584
G
Generic Name
megestrol acetate
Product Specifications
Route of AdministrationORAL
Effective DateJune 10, 2020
FDA Product Classification

INGREDIENTS (9)

MEGESTROL ACETATEActive
Quantity: 40 mg in 1 mL
Code: TJ2M0FR8ES
Classification: ACTIB
POLOXAMER 124Inactive
Code: 1S66E28KXA
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Megestrol Acetate - FDA Drug Approval Details