FDA Orange Book · active-ingredient family
Polyethylene glycol 3350
Polyethylene glycol 3350: 1 brand, 19 generics; first approved Jul 02, 2004; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 19 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
19
Listed patents
0
Presentations
30
Brand (NDA) products
Originator applications
- BAYER HEALTHCARE LLCNDA 02201520062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 17GM/SCOOPFUL FOR SOLUTION ORAL OTC — 17GM/PACKET FOR SOLUTION ORAL OTC —
Generic (ANDA) products (19)
Abbreviated applications
- POLYETHYLENE GLYCOL 3350LNK INTL INCANDA 21750520262 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 17GM/SCOOPFUL FOR SOLUTION ORAL OTC — 17GM/PACKET FOR SOLUTION ORAL OTC — - POLYETHYLENE GLYCOL 3350ANNORA PHARMAANDA 21499020212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 17GM/SCOOPFUL FOR SOLUTION ORAL OTC — 17GM/PACKET FOR SOLUTION ORAL OTC — - POLYETHYLENE GLYCOL 3350AUROBINDO PHARMA LTDANDA 20901720182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 17GM/SCOOPFUL FOR SOLUTION ORAL OTC — 17GM/PACKET FOR SOLUTION ORAL OTC — - POLYETHYLENE GLYCOL 3350NUVO PHARMS INCANDA 2061052016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 17GM/SCOOPFUL FOR SOLUTION ORAL OTC — - POLYETHYLENE GLYCOL 3350STRIDES PHARMAANDA 20392820162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 17GM/SCOOPFUL FOR SOLUTION ORAL OTC — 17GM/PACKET FOR SOLUTION ORAL OTC — - POLYETHYLENE GLYCOL 3350ANI PHARMSANDA 20285020152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 17GM/SCOOPFUL FOR SOLUTION ORAL OTC — 17GM/PACKET FOR SOLUTION ORAL OTC — - POLYETHYLENE GLYCOL 3350STRIDES PHARMA INTLANDA 0792142013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 17GM/SCOOPFUL FOR SOLUTION ORAL Discontinued — - POLYETHYLENE GLYCOL 3350SHREE HARI INTLANDA 2020712012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 17GM/SCOOPFUL FOR SOLUTION ORAL OTC — - POLYETHYLENE GLYCOL 3350PADDOCK LLCANDA 0905672009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 17GM/SCOOPFUL FOR SOLUTION ORAL Discontinued — - POLYETHYLENE GLYCOL 3350POINTVIEW HLDINGSANDA 0908122009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 17GM/SCOOPFUL FOR SOLUTION ORAL OTC — - LANNETT CO INCANDA 09060020092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 17GM/PACKET FOR SOLUTION ORAL Discontinued — 17GM/SCOOPFUL FOR SOLUTION ORAL Discontinued — - POLYETHYLENE GLYCOL 3350MYLANANDA 07891520092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 17GM/PACKET FOR SOLUTION ORAL OTC — 17GM/SCOOPFUL FOR SOLUTION ORAL OTC — - POLYETHYLENE GLYCOL 3350NOVEL LABS INCANDA 09107720092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 17GM/SCOOPFUL FOR SOLUTION ORAL OTC — 17GM/PACKET FOR SOLUTION ORAL OTC — - POLYETHYLENE GLYCOL 3350PPI-DACANDA 09068520092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 17GM/PACKET FOR SOLUTION ORAL OTC — 17GM/SCOOPFUL FOR SOLUTION ORAL OTC — - POLYETHYLENE GLYCOL 3350NEXGEN PHARMA INCANDA 0777062006
Approved strengths under this FDA application. Strength Dosage form Route Status TE 17GM/SCOOPFUL FOR SOLUTION ORAL Discontinued — - POLYETHYLENE GLYCOL 3350BRECKENRIDGE PHARMANDA 0777362006
Approved strengths under this FDA application. Strength Dosage form Route Status TE 17GM/SCOOPFUL FOR SOLUTION ORAL Discontinued — - POLYETHYLENE GLYCOL 3350PADDOCK LLCANDA 0778932006
Approved strengths under this FDA application. Strength Dosage form Route Status TE 17GM/SCOOPFUL FOR SOLUTION ORAL Discontinued — - POLYETHYLENE GLYCOL 3350TEVA PHARMSANDA 0774452006
Approved strengths under this FDA application. Strength Dosage form Route Status TE 17GM/SCOOPFUL FOR SOLUTION ORAL Discontinued — - LANNETT CO INCANDA 0766522004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 17GM/SCOOPFUL FOR SOLUTION ORAL Discontinued —
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
22 yr 6 mo ago
Most recent approval
2 mo ago
Approvals span 2004–2026 across 20 FDA applications.
Brand (NDA) 15%
Generic (ANDA) 1995%
Polyethylene glycol 3350: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
