Orange Book product · Generic (ANDA)
ZALEPLON
ZALEPLON
At a glance
Jun 20, 2008
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 20, 2008
18 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
ZALEPLON
Strength
5MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
ANDA 077505
Product number
001
Marketing status
RX
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 078147 · HIKMA PHARMS
- 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.
