FDA Orange Book · active-ingredient family
Flurazepam hydrochloride
Flurazepam hydrochloride is approved as 1 brand and 21 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DALMANE · NDA 016721
1
Brand (NDA)
21
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DALMANERLD×2 | VALEANT PHARM INTL | NDA 016721 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (21)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FLURAZEPAM HYDROCHLORIDE×2 | RISING | ANDA 071717 | — | Jul 31, 1991 | |
| FLURAZEPAM HYDROCHLORIDE | CHARTWELL RX | ANDA 072368 | AB | Mar 30, 1989 | |
| FLURAZEPAM HYDROCHLORIDE | CHARTWELL RX | ANDA 072369 | AB | Mar 30, 1989 | |
| FLURAZEPAM HYDROCHLORIDE | SUPERPHARM | ANDA 071659 | — | Aug 04, 1988 | |
| FLURAZEPAM HYDROCHLORIDE | SUPERPHARM | ANDA 071660 | — | Aug 04, 1988 | |
| FLURAZEPAM HYDROCHLORIDE | HALSEY | ANDA 071808 | — | Jan 07, 1988 | |
| FLURAZEPAM HYDROCHLORIDE | HALSEY | ANDA 071809 | — | Jan 07, 1988 | |
| FLURAZEPAM HYDROCHLORIDE | WARNER CHILCOTT | ANDA 071767 | — | Dec 04, 1987 | |
| FLURAZEPAM HYDROCHLORIDE | WARNER CHILCOTT | ANDA 071768 | — | Dec 04, 1987 | |
| FLURAZEPAM HYDROCHLORIDE | PUREPAC PHARM | ANDA 071927 | — | Sep 09, 1987 | |
| FLURAZEPAM HYDROCHLORIDE | PUREPAC PHARM | ANDA 071551 | — | Sep 09, 1987 | |
| FLURAZEPAM HYDROCHLORIDE | USL PHARMA | ANDA 070562 | — | Jul 09, 1987 | |
| FLURAZEPAM HYDROCHLORIDE | USL PHARMA | ANDA 070563 | — | Jul 09, 1987 | |
| FLURAZEPAM HYDROCHLORIDE×2 | HIKMA INTL PHARMS | ANDA 071108 | — | Dec 08, 1986 | |
| FLURAZEPAM HYDROCHLORIDE | CHARTWELL RX | ANDA 071205 | — | Nov 25, 1986 | |
| FLURAZEPAM HYDROCHLORIDE | CHARTWELL RX | ANDA 071068 | — | Nov 25, 1986 | |
| FLURAZEPAM HYDROCHLORIDE | SUN PHARM INDUSTRIES | ANDA 070454 | — | Aug 04, 1986 | |
| FLURAZEPAM HYDROCHLORIDE | SUN PHARM INDUSTRIES | ANDA 070455 | — | Aug 04, 1986 | |
| FLURAZEPAM HYDROCHLORIDE | NOVITIUM PHARMA | ANDA 070444 | — | Mar 20, 1986 | |
| FLURAZEPAM HYDROCHLORIDE | NOVITIUM PHARMA | ANDA 070445 | — | Mar 20, 1986 | |
| FLURAZEPAM HYDROCHLORIDE×2 | RISING | ANDA 070345 | AB | Nov 27, 1985 |
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.
Flurazepam hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
