Orange Book product · Brand (NDA)
SUSTIVA
EFAVIRENZ
At a glance
Sep 17, 1998
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 17, 1998
28 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
EFAVIRENZ
Strength
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 020972
Product number
002
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.
- 2002SUSTIVABrand (NDA)
NDA 021360 · BRISTOL MYERS SQUIBB
- 2024EFAVIRENZGeneric (ANDA)
ANDA 091579 · MACLEODS PHARMS LTD
- 2021EFAVIRENZGeneric (ANDA)
ANDA 078509 · STRIDES PHARMA
- 2018EFAVIRENZGeneric (ANDA)
ANDA 077673 · AUROBINDO PHARMA LTD
- 2018EFAVIRENZGeneric (ANDA)
ANDA 205322 · AUROBINDO PHARMA
- 2018EFAVIRENZGeneric (ANDA)
ANDA 204766 · CIPLA
- 2018EFAVIRENZGeneric (ANDA)
ANDA 078886 · HETERO LABS LTD III
- 2018EFAVIRENZGeneric (ANDA)
ANDA 204869 · PHARMOBEDIENT
- 2017EFAVIRENZGeneric (ANDA)
ANDA 078064 · AUROBINDO PHARMA
- 2016EFAVIRENZGeneric (ANDA)
ANDA 091471 · MYLAN
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.
