Details for New Drug Application (NDA): 091077
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NDA 091077 describes POLYETHYLENE GLYCOL 3350, which is a drug marketed by Ani Pharms, Annora Pharma, Aurobindo Pharma Ltd, Breckenridge Pharm, Lgm Pharma, Mylan, Nexgen Pharma Inc, Novel Labs Inc, Nuvo Pharms Inc, Paddock Llc, Ppi-dac, Shree Hari Intl, Strides Pharma, Strides Pharma Intl, and Teva Pharms, and is included in eighteen 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 four hundred and twenty-one drug master file entries for this compound. Six 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 four hundred and twenty-one drug master file entries for this compound. Six 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 091077
| Tradename: | POLYETHYLENE GLYCOL 3350 |
| Applicant: | Novel Labs Inc |
| Ingredient: | polyethylene glycol 3350 |
| Patents: | 0 |
Pharmacology for NDA: 091077
| Mechanism of Action | Osmotic Activity |
| Physiological Effect | Stimulation Large Intestine Fluid/Electrolyte Secretion |
Suppliers and Packaging for NDA: 091077
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| POLYETHYLENE GLYCOL 3350 | polyethylene glycol 3350 | FOR SOLUTION;ORAL | 091077 | ANDA | ATLANTIC BIOLOGICALS CORP. | 17856-0312 | 17856-0312-1 | 17 g in 1 BAG (17856-0312-1) |
| POLYETHYLENE GLYCOL 3350 | polyethylene glycol 3350 | FOR SOLUTION;ORAL | 091077 | ANDA | ATLANTIC BIOLOGICALS CORP. | 17856-0312 | 17856-0312-2 | 8.5 g in 1 BAG (17856-0312-2) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | FOR SOLUTION;ORAL | Strength | 17GM/SCOOPFUL | ||||
| Approval Date: | Oct 6, 2009 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | OTC | Dosage: | FOR SOLUTION;ORAL | Strength | 17GM/PACKET | ||||
| Approval Date: | Jun 27, 2011 | TE: | RLD: | No | |||||
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