Orange Book product · Brand (NDA)
DALMANE
FLURAZEPAM HYDROCHLORIDE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
FLURAZEPAM HYDROCHLORIDE
Strength
15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 016721
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 1991FLURAZEPAM HYDROCHLORIDEGeneric (ANDA)
ANDA 071717 · RISING
- 1989FLURAZEPAM HYDROCHLORIDEGeneric (ANDA)
ANDA 072368 · CHARTWELL RX
- 1989FLURAZEPAM HYDROCHLORIDEGeneric (ANDA)
ANDA 072369 · CHARTWELL RX
- 1988FLURAZEPAM HYDROCHLORIDEGeneric (ANDA)
ANDA 071659 · SUPERPHARM
- 1988FLURAZEPAM HYDROCHLORIDEGeneric (ANDA)
ANDA 071660 · SUPERPHARM
- 1988FLURAZEPAM HYDROCHLORIDEGeneric (ANDA)
ANDA 071808 · HALSEY
- 1988FLURAZEPAM HYDROCHLORIDEGeneric (ANDA)
ANDA 071809 · HALSEY
- 1987FLURAZEPAM HYDROCHLORIDEGeneric (ANDA)
ANDA 071767 · WARNER CHILCOTT
- 1987FLURAZEPAM HYDROCHLORIDEGeneric (ANDA)
ANDA 071768 · WARNER CHILCOTT
- 1987FLURAZEPAM HYDROCHLORIDEGeneric (ANDA)
ANDA 071927 · PUREPAC PHARM
- 1987FLURAZEPAM HYDROCHLORIDEGeneric (ANDA)
ANDA 071551 · PUREPAC PHARM
- 1987FLURAZEPAM HYDROCHLORIDEGeneric (ANDA)
ANDA 070562 · USL PHARMA
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.
