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Details for New Drug Application (NDA): 202123

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NDA 202123 describes COMPLERA, which is a drug marketed by Gilead Sciences Inc and is included in one NDA. It is available from three suppliers. There are seventeen patents protecting this drug and one Paragraph IV challenge. Additional details are available on the COMPLERA profile page.

The generic ingredient in COMPLERA is emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate. There are fifteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate profile page.

Summary for NDA: 202123

Tradename:
COMPLERA
Applicant:
Gilead Sciences Inc
Ingredient:
emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
Patents:17
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 202123

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
COMPLERA
emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
TABLET;ORAL 202123 NDA A-S Medication Solutions 50090-1248 50090-1248-0 30 TABLET, FILM COATED in 1 BOTTLE (50090-1248-0)
COMPLERA
emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
TABLET;ORAL 202123 NDA A-S Medication Solutions 54569-6270 54569-6270-0 30 TABLET, FILM COATED in 1 BOTTLE (54569-6270-0)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG;EQ 25MG BASE;300MG
Approval Date:Aug 10, 2011TE:RLD:Yes
Patent:5,814,639*PEDPatent Expiration:Mar 29, 2016Product Flag?Substance Flag?Delist Request?Y
Patent:5,914,331*PEDPatent Expiration:Jan 2, 2018Product Flag?Substance Flag?Delist Request?Y
Patent:5,922,695*PEDPatent Expiration:Jan 25, 2018Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 202123

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead Sciences Inc
COMPLERA
emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
TABLET;ORAL202123-001Aug 10, 20115,814,639*PED► subscribe
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