Atazanavir / cobicistat Oral Tablet
- Brand(s)
- Evotaz
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- E.R. Squibb & Sons, L.L.C. (2015-06-01)
- Oldest Current Product
- 2015-01-29
- License(s)
- NDA
- RxNORM
- ORAL TABLET\ATAZANAVIR:COBICISTAT
- FDAOB
- ORAL\TABLET\ATAZANAVIR SULFATE: COBICISTAT
- SPL Active
- ORAL\TABLET\ATAZANAVIR SULFATE: COBICISTAT
- SPL Moiety
- ORAL\TABLET\ATAZANAVIR: COBICISTAT
product(s) by strength(s)
atazanavir 300 mg / cobicistat 150 mg oral tablet
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 000033641 | Evotaz | NDA | E.R. Squibb & Sons, L.L.C. | 2015-01-29 | ATAZANAVIR SULFATE, COBICISTAT | ORAL | TABLET | NDA206353 | 83db29d7-5d85-49d6-8cb6-740473365cf8 |
application(s)
| # | id | title | applicant | approved | patent | approved drug |
|---|---|---|---|---|---|---|
| 1 | NDA206353 | EVOTAZ | BRISTOL MYERS SQUIBB | 2015-01-29 | p8148374, TREATMENT OF HIV INFECTION USING A COMPOSITION CONTAINING A PHARMACOKNIETIC ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENASE, SUBSTANCE p5849911, METHOD FOR TREATING HIV-1 INFECTION, SUBSTANCE p6087383, SUBSTANCE | NDA206353_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | NDA206353_001 | RX | COBICISTAT (150MG), ATAZANAVIR SULFATE (EQ 300MG BASE) | ORAL | TABLET | True | 2015-01-29 | EVOTAZ |
patent(s)
| # | id | expiration date | application(s) | in other drug docs |
|---|---|---|---|---|
| 1 | p5849911 (view patent) | 2017-06-20 | NDA206353, NDA021567, NDA206352 | Atazanavir Oral Powder Atazanavir Oral Capsule |
| 2 | p6087383 (view patent) | 2018-12-21 | NDA206353, NDA021567, NDA206352 | Atazanavir Oral Powder Atazanavir Oral Capsule |
| 3 | p8148374 (view patent) | 2029-09-03 | NDA206353, NDA203094, NDA203100, NDA205395 | cobicistat / elvitegravir / emtricitabine / tenofovir disoproxil Oral Tablet cobicistat Oral Tablet cobicistat / darunavir Oral Tablet |
spl(s)
| # | id | title | category | type | labeler | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|
| 1 | 83db29d7-5d85-49d6-8cb6-740473365cf8 (view SPL) | These highlights do not include all the information needed to use EVOTAZ safely and effectively. See full prescribing information for EVOTAZ. EVOTAZ (atazanavir and cobicistat) tablet, for oral useInitial U.S. Approval: 2015 | prescription | Human Prescription | E.R. Squibb & Sons, L.L.C. | 2015-06-01 | 3 | 000033641 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII