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Megestrol Acetate

MEGESTROL ACETATE ORAL SUSPENSION, USPRx Only

Approved
Approval ID

ad17ca75-427d-426c-9813-040eb9729612

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 2, 2021

Manufacturers
FDA

VistaPharm, Inc.

DUNS: 116743084

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 Code66689-020
Application NumberANDA075671
Product Classification
M
Marketing Category
C73584
G
Generic Name
Megestrol Acetate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 2, 2021
FDA Product Classification

INGREDIENTS (9)

MEGESTROL ACETATEActive
Quantity: 40 mg in 1 mL
Code: TJ2M0FR8ES
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT

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Megestrol Acetate - FDA Drug Approval Details