Orange Book product · Generic (ANDA)
LACTULOSE
LACTULOSE
At a glance
Dec 13, 2024
Approved
Generic (ANDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 13, 2024
1 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
LACTULOSE
Strength
10GM/15ML
Dosage form
SOLUTION
Route
ORAL
TE code
AA
Application
ANDA 218858
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of LACTULOSE
- —CHRONULACBrand (NDA)
NDA 017884 · SANOFI AVENTIS US
- —CEPHULACBrand (NDA)
NDA 017657 · SANOFI AVENTIS US
- —LACTULOSEBrand (NDA)
NDA 017906 · SOLVAY
- 2025LACTULOSEGeneric (ANDA)
ANDA 217914 · PAI HOLDINGS
- 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.
