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Last Updated: July 3, 2020

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Details for New Drug Application (NDA): 204399


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NDA 204399 describes VOGELXO, which is a drug marketed by Upsher Smith Labs and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the VOGELXO profile page.

The generic ingredient in VOGELXO is testosterone. There are sixty-nine drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the testosterone profile page.
Summary for 204399
Tradename:VOGELXO
Applicant:Upsher Smith Labs
Ingredient:testosterone
Patents:3
Formulation / Manufacturing:see details
Pharmacology for NDA: 204399
Mechanism of ActionAndrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for 204399
Suppliers and Packaging for NDA: 204399
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VOGELXO testosterone GEL, METERED;TRANSDERMAL 204399 NDA Upsher-Smith Laboratories, LLC 0245-0871 0245-0871-05 30 TUBE in 1 CARTON (0245-0871-05) > 5 g in 1 TUBE (0245-0871-65)
VOGELXO testosterone GEL, METERED;TRANSDERMAL 204399 NDA Upsher-Smith Laboratories, LLC 0245-0871 0245-0871-35 30 PACKET in 1 CARTON (0245-0871-35) > 5 g in 1 PACKET (0245-0871-89)

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:GEL;TRANSDERMALStrength50MG/5GM PACKET
Approval Date:Jun 4, 2014TE:AB2RLD:No
Patent:  Start TrialPatent Expiration:Feb 11, 2034Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD FOR TRANSDERMAL DELIVERY OF TESTOSTERONE
Patent:  Start TrialPatent Expiration:Feb 11, 2034Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD FOR TRANSDERMAL DELIVERY OF TESTOSTERONE
Patent:  Start TrialPatent Expiration:Feb 11, 2034Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD FOR TRANSDERMAL DELIVERY OF TESTOSTERONE

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