Orange Book product · Brand (NDA)
CEPHULAC
LACTULOSE
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
LACTULOSE
Strength
10GM/15ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SOLUTION
Route
ORAL, RECTAL
TE code
Not listed
Application
NDA 017657
Product number
001
Marketing status
DISCN
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.
- —CHRONULACBrand (NDA)
NDA 017884 · SANOFI AVENTIS US
- —LACTULOSEBrand (NDA)
NDA 017906 · SOLVAY
- 2025LACTULOSEGeneric (ANDA)
ANDA 217914 · PAI HOLDINGS
- 2024LACTULOSEGeneric (ANDA)
ANDA 218858 · TARO
- 2018LACTULOSEGeneric (ANDA)
ANDA 209517 · CHARTWELL RX
- 2018LACTULOSEGeneric (ANDA)
ANDA 207786 · APOZEAL PHARMS
- 2015LACTULOSEGeneric (ANDA)
ANDA 203762 · SCIEGEN PHARMS
- 2012LACTULOSEGeneric (ANDA)
ANDA 090503 · FRESENIUS KABI
- 2012LACTULOSEGeneric (ANDA)
ANDA 090502 · FRESENIUS KABI
- 2008LACTULOSEGeneric (ANDA)
ANDA 090426 · ANI PHARMS
- 2007LACTULOSEGeneric (ANDA)
ANDA 078430 · ANI PHARMS
- 2003LACTULOSEGeneric (ANDA)
ANDA 076645 · BAJAJ
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.
