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Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021463

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NDA 021463 describes FORTESTA, which is a drug marketed by Endo Pharms and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the FORTESTA profile page.

The generic ingredient in FORTESTA is testosterone. There are sixty-three drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the testosterone profile page.
Summary for 021463
Tradename:FORTESTA
Applicant:Endo Pharms
Ingredient:testosterone
Patents:2
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Pharmacology for NDA: 021463
Ingredient-typeAndrostanes
Mechanism of ActionAndrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for 021463
Suppliers and Packaging for NDA: 021463
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FORTESTA testosterone GEL, METERED;TRANSDERMAL 021463 NDA AUTHORIZED GENERIC Par Pharmaceutical 0603-7831 N 0603-7831-88
FORTESTA testosterone GEL, METERED;TRANSDERMAL 021463 NDA Endo Pharmaceuticals, Inc. 63481-183 N 63481-183-16

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL, METERED;TRANSDERMALStrength10MG/0.5GM ACTUATION
Approval Date:Dec 29, 2010TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Nov 9, 2018Product Flag?Substance Flag?Delist Request?
Patented Use:TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
Patent:➤ Sign UpPatent Expiration:Nov 9, 2018Product Flag?YSubstance Flag?Delist Request?

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