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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 two patents protecting this drug. Additional details are available on the VOGELXO profile page.

The generic ingredient in VOGELXO 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: 204399

Tradename:
VOGELXO
Applicant:
Upsher-smith Labs
Ingredient:
testosterone
Patents:2
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for NDA: 204399

Ingredient-typeAndrostanes
Mechanism of ActionAndrogen Receptor Agonists

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, Inc. 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, Inc. 0245-0871 0245-0871-35 30 PACKET in 1 CARTON (0245-0871-35) > 5 g in 1 PACKET (0245-0871-89)

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:GEL;TRANSDERMALStrength50MG/5GM PACKET
Approval Date:Jun 4, 2014TE:AB2RLD:No
Patent:8,785,426Patent Expiration:Feb 11, 2034Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD FOR TRANSDERMAL DELIVERY OF TESTOSTERONE
Patent:9,295,675Patent Expiration:Feb 11, 2034Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD FOR TRANSDERMAL DELIVERY OF TESTOSTERONE
Regulatory Exclusivity Expiration:Jun 4, 2017
Regulatory Exclusivity Use:NEW PRODUCT


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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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