Details for New Drug Application (NDA): 217505
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NDA 217505 describes POLYETHYLENE GLYCOL 3350, which is a drug marketed by Ani Pharms, Annora Pharma, Aurobindo Pharma Ltd, Breckenridge Pharm, Lnk Intl Inc, Mylan, Nexgen Pharma Inc, Novel Labs Inc, Nuvo Pharms Inc, Paddock Llc, Pointview Hldings, Ppi-dac, Shree Hari Intl, Strides Pharma, Strides Pharma Intl, and Teva Pharms, and is included in nineteen NDAs. It is available from seventy-one suppliers. Additional details are available on the POLYETHYLENE GLYCOL 3350 profile page.
The generic ingredient in POLYETHYLENE GLYCOL 3350 is polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous. There are two drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous profile page.
The generic ingredient in POLYETHYLENE GLYCOL 3350 is polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous. There are two drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous profile page.
Summary for 217505
| Tradename: | POLYETHYLENE GLYCOL 3350 |
| Applicant: | Lnk Intl Inc |
| Ingredient: | polyethylene glycol 3350 |
| Patents: | 0 |
Pharmacology for NDA: 217505
| Mechanism of Action | Osmotic Activity |
| Physiological Effect | Stimulation Large Intestine Fluid/Electrolyte Secretion |
Suppliers and Packaging for NDA: 217505
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| POLYETHYLENE GLYCOL 3350 | polyethylene glycol 3350 | FOR SOLUTION;ORAL | 217505 | ANDA | Major Pharmaceuticals | 0904-7534 | 0904-7534-26 | 15 PACKET in 1 CARTON (0904-7534-26) / 17 g in 1 PACKET |
| POLYETHYLENE GLYCOL 3350 | polyethylene glycol 3350 | FOR SOLUTION;ORAL | 217505 | ANDA | Major Pharmaceuticals | 0904-7534 | 0904-7534-86 | 17 g in 1 PACKET (0904-7534-86) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | FOR SOLUTION;ORAL | Strength | 17GM/SCOOPFUL | ||||
| Approval Date: | Jul 29, 2026 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | OTC | Dosage: | FOR SOLUTION;ORAL | Strength | 17GM/PACKET | ||||
| Approval Date: | Jul 29, 2026 | TE: | RLD: | No | |||||
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