Orange Book product · Generic (ANDA)
EFAVIRENZ
EFAVIRENZ
At a glance
Dec 15, 2017
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 15, 2017
8 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
EFAVIRENZ
Strength
50MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
ANDA 078064
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of EFAVIRENZ
- 2002SUSTIVABrand (NDA)
NDA 021360 · BRISTOL MYERS SQUIBB
- 1998SUSTIVABrand (NDA)
NDA 020972 · 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
- 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.
