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Last Updated: July 7, 2020

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Details for New Drug Application (NDA): 022332

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NDA 022332 describes ADCIRCA, which is a drug marketed by Eli Lilly Co and is included in one NDA. It is available from two suppliers. Additional details are available on the ADCIRCA profile page.

The generic ingredient in ADCIRCA is tadalafil. There are twenty-five drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the tadalafil profile page.
Summary for 022332
Applicant:Eli Lilly Co
Formulation / Manufacturing:see details
Pharmacology for NDA: 022332
Medical Subject Heading (MeSH) Categories for 022332
Suppliers and Packaging for NDA: 022332
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ADCIRCA tadalafil TABLET;ORAL 022332 NDA Aphena Pharma Solutions - Tennessee, LLC 43353-070 43353-070-12 12 TABLET in 1 BOTTLE (43353-070-12)
ADCIRCA tadalafil TABLET;ORAL 022332 NDA United Therapeutics Corporation 66302-467 66302-467-60 60 TABLET in 1 BOTTLE (66302-467-60)
Paragraph IV (Patent) Challenges for 022332
Tradename Dosage Ingredient NDA Submissiondate
ADCIRCA TABLET;ORAL tadalafil 022332 2009-10-15

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:May 22, 2009TE:AB2RLD:Yes

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