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Generated: August 19, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020264

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NDA 020264 describes MEGACE, which is a drug marketed by Bristol Myers Squibb and Endo Pharms Inc and is included in three NDAs. It is available from one supplier. There are six patents protecting this drug and one Paragraph IV challenge. Additional details are available on the MEGACE profile page.

The generic ingredient in MEGACE is megestrol acetate. There are eighteen drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the megestrol acetate profile page.

Summary for NDA: 020264

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for NDA: 020264

Ingredient-typeProgesterone Congeners

Suppliers and Packaging for NDA: 020264

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEGACE
megestrol acetate
SUSPENSION;ORAL 020264 NDA E.R. Squibb & Sons, L.L.C. 0015-0508 0015-0508-42 1 BOTTLE in 1 CARTON (0015-0508-42) > 240 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SUSPENSION;ORALStrength40MG/ML
Approval Date:Sep 10, 1993TE:RLD:Yes

Expired Orange Book Patents for NDA: 020264

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb
MEGACE
megestrol acetate
SUSPENSION;ORAL020264-001Sep 10, 1993► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

McKesson
Express Scripts
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Colorcon
Cipla
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Fuji

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