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Details for New Drug Application (NDA): 203100

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NDA 203100 describes STRIBILD, which is a drug marketed by Gilead Sciences Inc and is included in one NDA. It is available from three suppliers. There are sixteen patents protecting this drug. Additional details are available on the STRIBILD profile page.

The generic ingredient in STRIBILD is cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate. There are five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate profile page.

Suppliers and Packaging for NDA: 203100

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
STRIBILD
cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL 203100 NDA A-S Medication Solutions 50090-1318 50090-1318-0 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-1318-0)
STRIBILD
cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL 203100 NDA State of Florida DOH Central Pharmacy 53808-0887 53808-0887-1 30 TABLET, FILM COATED in 1 BLISTER PACK (53808-0887-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG;150MG;200MG;300MG
Approval Date:Aug 27, 2012TE: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: 203100

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead Sciences Inc
STRIBILD
cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL203100-001Aug 27, 20125,814,639*PED► subscribe
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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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