Megestrol Acetate
MEGESTROL ACETATE ORAL SUSPENSION, USP
Approved
Approval ID
582cff8a-1def-43d6-ba7e-dce49e3e9f27
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 14, 2023
Manufacturers
FDA
Natco Pharma USA LLC
DUNS: 079590418
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 Code69339-160
Application NumberANDA075671
Product Classification
M
Marketing Category
C73584
G
Generic Name
Megestrol Acetate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 14, 2023
FDA Product Classification
INGREDIENTS (8)
MEGESTROL ACETATEActive
Quantity: 40 mg in 1 mL
Code: TJ2M0FR8ES
Classification: ACTIB
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT