Orange Book product · Brand (NDA)
AMBIEN CR
ZOLPIDEM TARTRATE
At a glance
Sep 02, 2005
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 02, 2005
21 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
ZOLPIDEM TARTRATE
Strength
6.25MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
AB
Application
NDA 021774
Product number
002
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.
- 2023ZOLPIDEM TARTRATEBrand (NDA)
NDA 215721 · ALMATICA
- 2011INTERMEZZOBrand (NDA)
NDA 022328 · PURDUE PHARMA
- 2009EDLUARBrand (NDA)
NDA 021997 · VIATRIS
- 2008ZOLPIMISTBrand (NDA)
NDA 022196 · AYTU
- 2007TOVALT ODTBrand (NDA)
NDA 021412 · BIOVAIL LABS INTL
- 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.
