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Megestrol Acetate

MEGESTROL ACETATE TABLETS USP, 20 MG AND 40 MG

Approved
Approval ID

8f8017b4-4645-4ec2-9603-945b17e2753f

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 7, 2010

Manufacturers
FDA

State of Florida DOH Central Pharmacy

DUNS: 829348114

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 Code53808-0614
Application NumberANDA074458
Product Classification
M
Marketing Category
C73584
G
Generic Name
MEGESTROL ACETATE
Product Specifications
Route of AdministrationORAL
Effective DateJune 7, 2010
FDA Product Classification

INGREDIENTS (7)

MEGESTROL ACETATEActive
Quantity: 40 mg in 1 1
Code: TJ2M0FR8ES
Classification: ACTIB
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

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Megestrol Acetate - FDA Drug Approval Details