Orange Book product · Generic (ANDA)
EFAVIRENZ
EFAVIRENZ
At a glance
Mar 12, 2018
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 12, 2018
8 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
EFAVIRENZ
Strength
600MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 204869
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
- 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.

