FDA Orange Book · active-ingredient family
Polyethylene glycol 3350
Polyethylene glycol 3350 is approved as 1 brand and 18 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:MIRALAX · NDA 022015
1
Brand (NDA)
18
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · for solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MIRALAXRLD×2 | BAYER HEALTHCARE LLC | NDA 022015 | — | Oct 06, 2006 |
Generic (ANDA) products (18)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| POLYETHYLENE GLYCOL 3350×2 | ANNORA PHARMA | ANDA 214990 | — | Apr 14, 2021 | |
| POLYETHYLENE GLYCOL 3350×2 | AUROBINDO PHARMA LTD | ANDA 209017 | — | Apr 09, 2018 | |
| POLYETHYLENE GLYCOL 3350 | NUVO PHARMS INC | ANDA 206105 | — | Oct 28, 2016 | |
| POLYETHYLENE GLYCOL 3350×2 | STRIDES PHARMA | ANDA 203928 | — | Aug 24, 2016 | |
| POLYETHYLENE GLYCOL 3350×2 | ANI PHARMS | ANDA 202850 | — | Dec 15, 2015 | |
| POLYETHYLENE GLYCOL 3350 | STRIDES PHARMA INTL | ANDA 079214 | — | Jan 31, 2013 | |
| POLYETHYLENE GLYCOL 3350 | SHREE HARI INTL | ANDA 202071 | — | Dec 28, 2012 | |
| POLYETHYLENE GLYCOL 3350 | PADDOCK LLC | ANDA 090567 | — | Oct 15, 2009 | |
| POLYETHYLENE GLYCOL 3350 | ALLIED | ANDA 090812 | — | Oct 07, 2009 | |
| GLYCOLAX×2 | LANNETT CO INC | ANDA 090600 | — | Oct 06, 2009 | |
| POLYETHYLENE GLYCOL 3350×2 | MYLAN | ANDA 078915 | — | Oct 06, 2009 | |
| POLYETHYLENE GLYCOL 3350×2 | NOVEL LABS INC | ANDA 091077 | — | Oct 06, 2009 | |
| POLYETHYLENE GLYCOL 3350×2 | PPI-DAC | ANDA 090685 | — | Oct 06, 2009 | |
| POLYETHYLENE GLYCOL 3350 | NEXGEN PHARMA INC | ANDA 077706 | — | Sep 27, 2006 | |
| POLYETHYLENE GLYCOL 3350 | BRECKENRIDGE PHARM | ANDA 077736 | — | May 26, 2006 | |
| POLYETHYLENE GLYCOL 3350 | PADDOCK LLC | ANDA 077893 | — | May 26, 2006 | |
| POLYETHYLENE GLYCOL 3350 | TEVA PHARMS | ANDA 077445 | — | May 04, 2006 | |
| GLYCOLAX | LANNETT CO INC | ANDA 076652 | — | Jul 02, 2004 |
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.
Polyethylene glycol 3350 — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
