FDA Orange Book · active-ingredient family
Polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous
Polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous: 2 brands, 11 generics; first approved Jul 13, 1984; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available — 11 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
11
Listed patents
0
Presentations
21
Originator applications
Brand (NDA) products
GOLYTELYRLDAZURITYNDA 01901119922 strengths
GOLYTELYRLD
AZURITYNDA 01901119922 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT | FOR SOLUTION | ORAL | Rx | AA |
| 227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET | FOR SOLUTION | ORAL | Discontinued | — |
COLYTERLDSTRIDES PHARMA INTLNDA 01898319848 strengths
COLYTERLD
STRIDES PHARMA INTLNDA 01898319848 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION | ORAL | Discontinued | — |
| 120GM/PACKET;1.49GM/PACKET;3.36GM/PACKET;2.92GM/PACKET;11.36GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION | ORAL | Discontinued | — |
| 360GM/PACKET;4.47GM/PACKET;10.08GM/PACKET;8.76GM/PACKET;34.08GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION | ORAL | Discontinued | — |
| 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION | ORAL | Discontinued | — |
| 227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION | ORAL | Discontinued | — |
| 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION | ORAL | Discontinued | — |
| 227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION | ORAL | Discontinued | — |
| 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT | FOR SOLUTION | ORAL | Discontinued | — |
Abbreviated applications
Generic (ANDA) products (11)
STRIDES PHARMAANDA 2045582018
STRIDES PHARMAANDA 2045582018
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT | FOR SOLUTION | ORAL | Rx | AA |
PADDOCK LLCANDA 0907122010
PADDOCK LLCANDA 0907122010
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT | FOR SOLUTION | ORAL | Discontinued | — |
EXTROVISANDA 0909282010
EXTROVISANDA 0909282010
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT | FOR SOLUTION | ORAL | Discontinued | — |
NOVEL LABS INCANDA 0902312009
NOVEL LABS INCANDA 0902312009
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT | FOR SOLUTION | ORAL | Rx | AA |
NOVEL LABS INCANDA 0901862009
NOVEL LABS INCANDA 0901862009
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT | FOR SOLUTION | ORAL | Rx | — |
SANDOZANDA 0730981993
SANDOZANDA 0730981993
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT | FOR SUSPENSION | ORAL | Discontinued | — |
VINTAGE PHARMSANDA 0734331992
VINTAGE PHARMSANDA 0734331992
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT | FOR SUSPENSION | ORAL | Discontinued | — |
VINTAGE PHARMSANDA 0734281992
VINTAGE PHARMSANDA 0734281992
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT | FOR SUSPENSION | ORAL | Discontinued | — |
GOLDLINEANDA 0723191988
GOLDLINEANDA 0723191988
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT | FOR SUSPENSION | ORAL | Discontinued | — |
E Z EMANDA 0712781988
E Z EMANDA 0712781988
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT | FOR SUSPENSION | ORAL | Discontinued | — |
DYNAPHARMANDA 0713201988
DYNAPHARMANDA 0713201988
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET | FOR SUSPENSION | ORAL | Discontinued | — |
Orange Book patent file
Listed patents
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.
FDA approval span
Approval history
First approval
Jul 13, 1984
42 yr 7 mo ago
Most recent approval
Dec 21, 2018
7 yr 8 mo ago
Approvals span 1984–2018 across 13 FDA applications.
Brand (NDA) 215%
Generic (ANDA) 1185%
Polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous — 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 BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
