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Generated: January 16, 2019

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Details for New Drug Application (NDA): 021778

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NDA 021778 describes MEGACE ES, which is a drug marketed by Endo Pharms Inc and is included in one NDA. It is available from four suppliers. There are six patents protecting this drug and one Paragraph IV challenge. Additional details are available on the MEGACE ES profile page.

The generic ingredient in MEGACE ES is megestrol acetate. There are eighteen drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the megestrol acetate profile page.
Summary for 021778
Tradename:MEGACE ES
Applicant:Endo Pharms Inc
Ingredient:megestrol acetate
Patents:6
Formulation / Manufacturing:see details
Pharmacology for NDA: 021778
Medical Subject Heading (MeSH) Categories for 021778
Suppliers and Packaging for NDA: 021778
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEGACE ES megestrol acetate SUSPENSION;ORAL 021778 NDA Atlantic Biologicals Corps 17856-0949 17856-0949-5 5 mL in 1 CUP (17856-0949-5)
MEGACE ES megestrol acetate SUSPENSION;ORAL 021778 NDA AUTHORIZED GENERIC Par Pharmaceutical, Inc. 49884-230 49884-230-69 150 mL in 1 BOTTLE (49884-230-69)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength125MG/ML
Approval Date:Jul 5, 2005TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Sep 21, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Apr 22, 2024Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ANOREXIA, CACHEXIA, OR AN UNEXPLAINED, SIGNIFICANT WEIGHT LOSS IN PATIENTS WITH A DIAGNOSIS OF ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS)
Patent:➤ Sign UpPatent Expiration:Apr 22, 2024Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ANOREXIA, CACHEXIA, OR AN UNEXPLAINED, SIGNIFICANT WEIGHT LOSS IN PATIENTS WITH A DIAGNOSIS OF ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS)

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