Orange Book product · Brand (NDA)
LUNESTA
ESZOPICLONE
At a glance
Dec 15, 2004
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 15, 2004
21 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
ESZOPICLONE
Strength
1MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 021476
Product number
001
Marketing status
RX
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.
- 2024ESZOPICLONEGeneric (ANDA)
ANDA 205504 · HETERO LABS LTD V
- 2023ESZOPICLONEGeneric (ANDA)
ANDA 206222 · IPCA LABS LTD
- 2019ESZOPICLONEGeneric (ANDA)
ANDA 203087 · PHARMOBEDIENT
- 2016ESZOPICLONEGeneric (ANDA)
ANDA 208451 · AUROBINDO PHARMA
- 2015ESZOPICLONEGeneric (ANDA)
ANDA 202929 · MACLEODS PHARMS LTD
- 2014ESZOPICLONEGeneric (ANDA)
ANDA 091113 · ORBION PHARMS
- 2014ESZOPICLONEGeneric (ANDA)
ANDA 091024 · DR REDDYS
- 2014ESZOPICLONEGeneric (ANDA)
ANDA 091166 · GLENMARK PHARMS LTD
- 2014ESZOPICLONEGeneric (ANDA)
ANDA 091153 · HIKMA
- 2013ESZOPICLONEGeneric (ANDA)
ANDA 091103 · SUN PHARM
- 2013ESZOPICLONEGeneric (ANDA)
ANDA 091151 · MYLAN PHARMS INC
- 2011ESZOPICLONEGeneric (ANDA)
ANDA 091124 · LUPIN LTD
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.
