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Details for New Drug Application (NDA): 022504

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NDA 022504 describes AXIRON, which is a drug marketed by Eli Lilly And Co and is included in one NDA. It is available from two suppliers. There are eleven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the AXIRON profile page.

The generic ingredient in AXIRON 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: 022504

Tradename:
AXIRON
Applicant:
Eli Lilly And Co
Ingredient:
testosterone
Patents:11
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for NDA: 022504

Ingredient-typeAndrostanes
Mechanism of ActionAndrogen Receptor Agonists

Suppliers and Packaging for NDA: 022504

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AXIRON
testosterone
SOLUTION, METERED;TRANSDERMAL 022504 NDA Eli Lilly and Company 0002-1975 0002-1975-61 1 BOTTLE, WITH APPLICATOR in 1 CARTON (0002-1975-61) > 90 mL in 1 BOTTLE, WITH APPLICATOR
AXIRON
testosterone
SOLUTION, METERED;TRANSDERMAL 022504 NDA Eli Lilly and Company 0002-1975 0002-1975-90 1 BOTTLE, WITH APPLICATOR in 1 CARTON (0002-1975-90) > 90 mL in 1 BOTTLE, WITH APPLICATOR

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION, METERED;TRANSDERMALStrength30MG/1.5ML ACTUATION
Approval Date:Nov 23, 2010TE:RLD:Yes
Patent:8,419,307Patent Expiration:Feb 26, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:A METHOD OF INCREASING THE TESTOSTERONE BLOOD LEVEL OF A PERSON IN NEED THEREOF
Patent:8,435,944Patent Expiration:Sep 27, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:A METHOD OF INCREASING THE TESTOSTERONE BLOOD LEVEL OF AN ADULT MALE SUBJECT IN NEED THEREOF
Patent:8,993,520Patent Expiration:Jun 2, 2026Product Flag?Substance Flag?Delist Request?
Patented Use:A METHOD OF INCREASING THE TESTOSTERONE BLOOD LEVEL OF AN ADULT MALE SUBJECT IN NEED THEREOF


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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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