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Last Updated: January 23, 2021

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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. Additional details are available on the FORTESTA profile page.

The generic ingredient in FORTESTA is testosterone. There are sixty-nine drug master file entries for this compound. Sixteen 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:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021463
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, Inc. 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
Paragraph IV (Patent) Challenges for 021463
Tradename Dosage Ingredient NDA Submissiondate
FORTESTA GEL, METERED;TRANSDERMAL testosterone 021463 2012-08-14

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL, METERED;TRANSDERMALStrength10MG/0.5GM ACTUATION
Approval Date:Dec 29, 2010TE:ABRLD:Yes

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Serving leading biopharmaceutical companies globally:

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Colorcon
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