Orange Book product · Brand (NDA)
ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE
At a glance
May 09, 2023
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 09, 2023
3 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
ZOLPIDEM TARTRATE
Strength
7.5MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
NDA 215721
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 2011INTERMEZZOBrand (NDA)
NDA 022328 · PURDUE PHARMA
- 2009EDLUARBrand (NDA)
NDA 021997 · VIATRIS
- 2008ZOLPIMISTBrand (NDA)
NDA 022196 · AYTU
- 2007TOVALT ODTBrand (NDA)
NDA 021412 · BIOVAIL LABS INTL
- 2005AMBIEN CRBrand (NDA)
NDA 021774 · COSETTE
- 1992AMBIENBrand (NDA)
NDA 019908 · COSETTE
- 2026ZOLPIDEM TARTRATEGeneric (ANDA)
ANDA 220717 · UMEDICA LABS PVT
- 2020ZOLPIDEM TARTRATEGeneric (ANDA)
ANDA 213592 · BRECKENRIDGE
- 2017ZOLPIDEM TARTRATEGeneric (ANDA)
ANDA 204229 · PH HEALTH
- 2017ZOLPIDEM TARTRATEGeneric (ANDA)
ANDA 204170 · SUN PHARM
- 2016ZOLPIDEM TARTRATEGeneric (ANDA)
ANDA 204503 · DR REDDYS
- 2016ZOLPIDEM TARTRATEGeneric (ANDA)
ANDA 202657 · PHARMOBEDIENT
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.
