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Details for New Drug Application (NDA): 022187

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NDA 022187 describes INTELENCE, which is a drug marketed by Janssen R And D and is included in one NDA. It is available from four suppliers. There are four patents protecting this drug. Additional details are available on the INTELENCE profile page.

The generic ingredient in INTELENCE is etravirine. There are five drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the etravirine profile page.

Summary for NDA: 022187

Tradename:
INTELENCE
Applicant:
Janssen R And D
Ingredient:
etravirine
Patents:4
Formulation / Manufacturing:see details

Pharmacology for NDA: 022187

Suppliers and Packaging for NDA: 022187

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INTELENCE
etravirine
TABLET;ORAL 022187 NDA State of Florida DOH Central Pharmacy 53808-0787 53808-0787-1 30 TABLET in 1 BLISTER PACK (53808-0787-1)
INTELENCE
etravirine
TABLET;ORAL 022187 NDA A-S Medication Solutions 54569-6102 54569-6102-0 120 TABLET in 1 BOTTLE (54569-6102-0)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Jan 18, 2008TE:RLD:No
Patent:7,887,845Patent Expiration:Mar 25, 2019Product Flag?YSubstance Flag?Delist Request?
Patent:8,003,789Patent Expiration:Nov 1, 2019Product Flag?YSubstance Flag?YDelist Request?
Patent:6,878,717Patent Expiration:Nov 5, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:COMBO W/ OTHER ANTIRETROVIRALS FOR TX OF HIV-1 IN ANTIRETROVIRAL TX-EXPERIENCED PT 6 YEARS UP, WHO HAVE EVIDENCE OF VIRAL REPLICATION AND HIV-1 STRAINS RESISTANT TO NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR AND OTHERANTIRETROVIRALS


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