Orange Book product · Generic (ANDA)
ZALEPLON
ZALEPLON
At a glance
Nov 25, 2008
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 25, 2008
17 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
ZALEPLON
Strength
5MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
ANDA 078147
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ZALEPLON
- 1999SONATABrand (NDA)
NDA 020859 · PFIZER
- 2009ZALEPLONGeneric (ANDA)
ANDA 090374 · ORBION PHARMS
- 2008ZALEPLONGeneric (ANDA)
ANDA 077505 · CHARTWELL MOLECULAR
- 2008ZALEPLONGeneric (ANDA)
ANDA 078829 · AUROBINDO PHARMA
- 2008ZALEPLONGeneric (ANDA)
ANDA 077237 · HIKMA
- 2008ZALEPLONGeneric (ANDA)
ANDA 077238 · NATCO PHARMA
- 2008ZALEPLONGeneric (ANDA)
ANDA 077239 · TEVA PHARMS
- 2008ZALEPLONGeneric (ANDA)
ANDA 078989 · UNICHEM
- 2008ZALEPLONGeneric (ANDA)
ANDA 078095 · UPSHER SMITH LABS
- 2008ZALEPLONGeneric (ANDA)
ANDA 078706 · UPSHER SMITH LABS
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.
