Orange Book product · Brand (NDA)
RESTORIL
TEMAZEPAM
At a glance
Oct 25, 1991
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 25, 1991
35 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
TEMAZEPAM
Strength
7.5MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
NDA 018163
Product number
003
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.
- 2023TEMAZEPAMGeneric (ANDA)
ANDA 217875 · ALKEM LABS LTD
- 2018TEMAZEPAMGeneric (ANDA)
ANDA 211542 · ALEMBIC
- 2016TEMAZEPAMGeneric (ANDA)
ANDA 203482 · AMNEAL PHARMS
- 2015TEMAZEPAMGeneric (ANDA)
ANDA 201781 · PRINSTON INC
- 2012TEMAZEPAMGeneric (ANDA)
ANDA 071457 · NOVEL LABS INC
- 2010TEMAZEPAMGeneric (ANDA)
ANDA 070920 · AUROBINDO PHARMA USA
- 2009TEMAZEPAMGeneric (ANDA)
ANDA 071175 · SUN PHARM INDUSTRIES
- 2009TEMAZEPAMGeneric (ANDA)
ANDA 078581 · SUN PHARM INDUSTRIES
- 1993TEMAZEPAMGeneric (ANDA)
ANDA 071446 · WATSON LABS
- 1993TEMAZEPAMGeneric (ANDA)
ANDA 071447 · WATSON LABS
- 1988TEMAZEPAMGeneric (ANDA)
ANDA 071708 · DURAMED PHARMS BARR
- 1988TEMAZEPAMGeneric (ANDA)
ANDA 071709 · DURAMED PHARMS BARR
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.
