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Last Updated: May 22, 2024

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. There are five 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. Fourteen 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:5
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 021778

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength125MG/ML
Approval Date:Jul 5, 2005TE:ABRLD:Yes
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)
Patent:⤷  Sign UpPatent Expiration:Apr 22, 2024Product Flag?YSubstance 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)

Expired US Patents for NDA 021778

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Endo Pharms Inc MEGACE ES megestrol acetate SUSPENSION;ORAL 021778-001 Jul 5, 2005 ⤷  Sign Up ⤷  Sign Up
Endo Pharms Inc MEGACE ES megestrol acetate SUSPENSION;ORAL 021778-001 Jul 5, 2005 ⤷  Sign Up ⤷  Sign Up
Endo Pharms Inc MEGACE ES megestrol acetate SUSPENSION;ORAL 021778-001 Jul 5, 2005 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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