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Details for New Drug Application (NDA): 022309

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NDA 022309 describes ANDROGEL, which is a drug marketed by Abbvie and is included in two NDAs. It is available from four suppliers. There are eleven patents protecting this drug and three Paragraph IV challenges. Additional details are available on the ANDROGEL profile page.

The generic ingredient in ANDROGEL is testosterone. There are sixty 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: 022309

Pharmacology for NDA: 022309

Mechanism of ActionAndrogen Receptor Agonists

Suppliers and Packaging for NDA: 022309

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GEL, METERED;TRANSDERMAL 022309 NDA AbbVie Inc. 0051-8462 0051-8462-30 30 PACKET in 1 CARTON (0051-8462-30) > 2.5 g in 1 PACKET (0051-8462-01)
GEL;TRANSDERMAL 022309 NDA AbbVie Inc. 0051-8462 0051-8462-30 30 PACKET in 1 CARTON (0051-8462-30) > 2.5 g in 1 PACKET (0051-8462-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL, METERED;TRANSDERMALStrength1.62% (20.25MG/1.25GM ACTUATION)
Approval Date:Apr 29, 2011TE:ABRLD:Yes
Patent:6,503,894*PEDPatent Expiration:Mar 2, 2021Product Flag?Substance Flag?Delist Request?Y
Patent:8,466,136Patent Expiration:Oct 12, 2026Product Flag?YSubstance Flag?Delist Request?
Patent:8,486,925Patent Expiration:Oct 12, 2026Product Flag?YSubstance Flag?Delist Request?

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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.