Orange Book product · Generic (ANDA)
LACTULOSE
LACTULOSE
At a glance
Dec 10, 1997
Approved
Generic (ANDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 10, 1997
28 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
LACTULOSE
Strength
10GM/PACKET
Dosage form
FOR SOLUTION
Route
ORAL
TE code
AA
Application
ANDA 074712
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
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
- 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
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.
