Orange Book product · Brand (NDA)
REYATAZ
ATAZANAVIR SULFATE
At a glance
Jun 20, 2003
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 20, 2003
23 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
ATAZANAVIR SULFATE
Strength
EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 021567
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2014REYATAZBrand (NDA)
NDA 206352 · BRISTOL MYERS SQUIBB
- 2022ATAZANAVIR SULFATEGeneric (ANDA)
ANDA 212278 · HETERO LABS LTD III
- 2021ATAZANAVIR SULFATEGeneric (ANDA)
ANDA 212579 · LAURUS
- 2020ATAZANAVIR SULFATEGeneric (ANDA)
ANDA 210575 · ZYDUS PHARMS
- 2020ATAZANAVIR SULFATEGeneric (ANDA)
ANDA 209717 · AMNEAL
- 2018ATAZANAVIR SULFATEGeneric (ANDA)
ANDA 208177 · MYLAN
- 2018ATAZANAVIR SULFATEGeneric (ANDA)
ANDA 200626 · CIPLA
- 2018ATAZANAVIR SULFATEGeneric (ANDA)
ANDA 204806 · AUROBINDO PHARMA
- 2014ATAZANAVIR SULFATEGeneric (ANDA)
ANDA 091673 · TEVA PHARMS USA
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
