Details for New Drug Application (NDA): 021937
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The generic ingredient in ATRIPLA is efavirenz; emtricitabine; tenofovir disoproxil fumarate. There are twenty-six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the efavirenz; emtricitabine; tenofovir disoproxil fumarate profile page.
Summary for 021937
Tradename: | ATRIPLA |
Applicant: | Gilead Sciences |
Ingredient: | efavirenz; emtricitabine; tenofovir disoproxil fumarate |
Patents: | 7 |
Suppliers and Packaging for NDA: 021937
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ATRIPLA | efavirenz; emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021937 | NDA | Gilead Sciences, LLC | 15584-0101 | 15584-0101-1 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (15584-0101-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 600MG;200MG;300MG | ||||
Approval Date: | Jul 12, 2006 | TE: | AB | RLD: | Yes | ||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jan 13, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | TREATMENT OF HIV-1 INFECTION IN ADULTS | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jan 13, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Apr 28, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? |
Expired US Patents for NDA 021937
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