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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 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: 021454

Tradename:
TESTIM
Applicant:
Auxilium Pharms
Ingredient:
testosterone
Patents:10
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for NDA: 021454

Ingredient-typeAndrostanes
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
TESTIM
testosterone
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
TESTIM
testosterone
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?
Patented Use:METHOD FOR ADMINISTRATION OF TESTOSTERONE
Patent:7,608,605Patent Expiration:Apr 21, 2023Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD FOR ADMINISTRATION OF TESTOSTERONE

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
TESTIM
testosterone
GEL;TRANSDERMAL021454-001Oct 31, 20025,023,252► subscribe
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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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