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Details for New Drug Application (NDA): 021454

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NDA 021454 describes TESTIM, which is a drug marketed by Auxilium Pharms and is included in one NDA. It is available from six suppliers. There are ten patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TESTIM profile page.

The generic ingredient in TESTIM is testosterone. There are fifty-nine 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: 021454

Pharmacology for NDA: 021454

Mechanism of ActionAndrogen Receptor Agonists

Suppliers and Packaging for NDA: 021454

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GEL;TRANSDERMAL 021454 NDA Stat Rx USA 16590-853 16590-853-30 30 TUBE in 1 PACKAGE (16590-853-30) > 5 g in 1 TUBE
GEL;TRANSDERMAL 021454 NDA Lake Erie Medical DBA Quality Care Products LLC 35356-758 35356-758-30 30 TUBE in 1 CARTON (35356-758-30) > 5 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TRANSDERMALStrength50MG/5GM PACKET
Approval Date:Oct 31, 2002TE:AB2RLD:Yes
Patent:8,178,518Patent Expiration:Apr 21, 2023Product Flag?YSubstance Flag?Delist Request?
Patent:7,320,968Patent Expiration:Jan 18, 2025Product Flag?Substance Flag?Delist Request?
Patent:7,608,605Patent Expiration:Apr 21, 2023Product Flag?Substance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021454

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Auxilium Pharms
GEL;TRANSDERMAL021454-001Oct 31, 20025,023,252<disabled>
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