Details for New Drug Application (NDA): 021752
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The generic ingredient in TRUVADA is emtricitabine; tenofovir disoproxil fumarate. There are eighteen drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the emtricitabine; tenofovir disoproxil fumarate profile page.
Summary for 021752
Tradename: | TRUVADA |
Applicant: | Gilead |
Ingredient: | emtricitabine; tenofovir disoproxil fumarate |
Patents: | 4 |
Pharmacology for NDA: 021752
Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Suppliers and Packaging for NDA: 021752
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TRUVADA | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021752 | NDA | Gilead Sciences, Inc | 61958-0701 | 61958-0701-1 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-0701-1) |
TRUVADA | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021752 | NDA | Gilead Sciences, Inc | 61958-0703 | 61958-0703-1 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-0703-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG;300MG | ||||
Approval Date: | Aug 2, 2004 | TE: | AB | RLD: | Yes | ||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jan 13, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | METHOD OF TREATMENT OF ADULTS INFECTED WITH HIV-1 | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jan 13, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | TREATMENT OF HIV | ||||||||
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 |
Expired US Patents for NDA 021752
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Gilead | TRUVADA | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021752-003 | Mar 10, 2016 | ⤷ Sign Up | ⤷ Sign Up |
Gilead | TRUVADA | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021752-003 | Mar 10, 2016 | ⤷ Sign Up | ⤷ Sign Up |
Gilead | TRUVADA | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021752-001 | Aug 2, 2004 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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