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FDA Approval

Megestrol Acetate

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Effective Date
June 7, 2010
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Megestrol acetate(40 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

State of Florida DOH Central Pharmacy

State of Florida DOH Central Pharmacy

829348114

Products1

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

Megestrol Acetate

Product Details

NDC Product Code
53808-0614
Application Number
ANDA074458
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
June 7, 2010
Code: TJ2M0FR8ESClass: ACTIBQuantity: 40 mg in 1 1
ACACIAInactive
Code: 5C5403N26OClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
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