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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-one drug master file entries for this compound. Nineteen suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the testosterone profile page.

Summary for NDA: 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

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 Qualitest Pharmaceuticals 0603-7831 0603-7831-88 1 CANISTER in 1 CARTON (0603-7831-88) > 60 g in 1 CANISTER
FORTESTA
testosterone
GEL, METERED;TRANSDERMAL 021463 NDA Endo Pharmaceuticals Inc. 63481-183 63481-183-16 1 CANISTER in 1 CARTON (63481-183-16) > 60 g in 1 CANISTER

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL, METERED;TRANSDERMALStrength10MG/0.5GM ACTUATION
Approval Date:Dec 29, 2010TE:ABRLD:Yes
Patent:6,579,865Patent Expiration:Nov 9, 2018Product Flag?YSubstance Flag?Delist Request?
Patent:6,319,913Patent 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


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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