Orange Book product · Generic (ANDA)
POLYETHYLENE GLYCOL 3350
POLYETHYLENE GLYCOL 3350
At a glance
Apr 09, 2018
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 09, 2018
8 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
POLYETHYLENE GLYCOL 3350
Strength
17GM/SCOOPFUL
Dosage form
FOR SOLUTION
Route
ORAL
TE code
Not listed
Application
ANDA 209017
Product number
001
Marketing status
OTC
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of POLYETHYLENE GLYCOL 3350
- 2006MIRALAXBrand (NDA)
NDA 022015 · BAYER HEALTHCARE LLC
- 2021POLYETHYLENE GLYCOL 3350Generic (ANDA)
ANDA 214990 · ANNORA PHARMA
- 2016POLYETHYLENE GLYCOL 3350Generic (ANDA)
ANDA 206105 · NUVO PHARMS INC
- 2016POLYETHYLENE GLYCOL 3350Generic (ANDA)
ANDA 203928 · STRIDES PHARMA
- 2015POLYETHYLENE GLYCOL 3350Generic (ANDA)
ANDA 202850 · ANI PHARMS
- 2013POLYETHYLENE GLYCOL 3350Generic (ANDA)
ANDA 079214 · STRIDES PHARMA INTL
- 2012POLYETHYLENE GLYCOL 3350Generic (ANDA)
ANDA 202071 · SHREE HARI INTL
- 2009POLYETHYLENE GLYCOL 3350Generic (ANDA)
ANDA 090567 · PADDOCK LLC
- 2009POLYETHYLENE GLYCOL 3350Generic (ANDA)
ANDA 090812 · ALLIED
- 2009GLYCOLAXGeneric (ANDA)
ANDA 090600 · LANNETT CO INC
- 2009POLYETHYLENE GLYCOL 3350Generic (ANDA)
ANDA 078915 · MYLAN
- 2009POLYETHYLENE GLYCOL 3350Generic (ANDA)
ANDA 091077 · NOVEL LABS INC
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.
