Details for New Drug Application (NDA): 208215
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The generic ingredient in DESCOVY is emtricitabine; tenofovir alafenamide fumarate. There are eighteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the emtricitabine; tenofovir alafenamide fumarate profile page.
Summary for 208215
Tradename: | DESCOVY |
Applicant: | Gilead Sciences Inc |
Ingredient: | emtricitabine; tenofovir alafenamide fumarate |
Patents: | 3 |
Pharmacology for NDA: 208215
Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Suppliers and Packaging for NDA: 208215
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DESCOVY | emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 208215 | NDA | Gilead Sciences, Inc. | 61958-2002 | 61958-2002-1 | 30 TABLET in 1 BOTTLE, PLASTIC (61958-2002-1) |
DESCOVY | emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 208215 | NDA | Gilead Sciences, Inc. | 61958-2002 | 61958-2002-2 | 30 TABLET in 1 BLISTER PACK (61958-2002-2) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG;EQ 25MG BASE | ||||
Approval Date: | Apr 4, 2016 | TE: | AB | RLD: | Yes | ||||
Patent: | ⤷ Try for Free | Patent Expiration: | Jul 7, 2025 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Patent: | ⤷ Try for Free | Patent Expiration: | Feb 15, 2033 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Patent: | ⤷ Try for Free | Patent Expiration: | Feb 15, 2033 | Product Flag? | Substance Flag? | Delist Request? | Y |
Expired US Patents for NDA 208215
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Gilead Sciences Inc | DESCOVY | emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 208215-001 | Apr 4, 2016 | ⤷ Try for Free | ⤷ Try for Free |
Gilead Sciences Inc | DESCOVY | emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 208215-001 | Apr 4, 2016 | ⤷ Try for Free | ⤷ Try for Free |
Gilead Sciences Inc | DESCOVY | emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 208215-001 | Apr 4, 2016 | ⤷ Try for Free | ⤷ Try for Free |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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