Details for New Drug Application (NDA): 209381
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NDA 209381 describes PLENVU, which is a drug marketed by Salix and is included in one NDA. It is available from one supplier. There are ten patents protecting this drug and one Paragraph IV challenge. Additional details are available on the PLENVU profile page.
The generic ingredient in PLENVU is ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate. There are six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate profile page.
The generic ingredient in PLENVU is ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate. There are six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate profile page.
Summary for 209381
| Tradename: | PLENVU |
| Applicant: | Salix |
| Ingredient: | ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate |
| Patents: | 10 |
Suppliers and Packaging for NDA: 209381
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PLENVU | ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate | FOR SOLUTION;ORAL | 209381 | NDA | Salix Pharmaceuticals, Inc | 65649-400 | 65649-400-01 | 1 KIT in 1 CARTON (65649-400-01) * 46.26 POWDER, FOR SOLUTION in 1 POUCH * 55.65 POWDER, FOR SOLUTION in 1 POUCH * 115.96 POWDER, FOR SOLUTION in 1 POUCH |
| PLENVU | ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate | FOR SOLUTION;ORAL | 209381 | NDA | Salix Pharmaceuticals, Inc | 65649-400 | 65649-400-02 | 1 KIT in 1 CARTON (65649-400-02) * 46.26 POWDER, FOR SOLUTION in 1 POUCH * 55.65 POWDER, FOR SOLUTION in 1 POUCH * 115.96 POWDER, FOR SOLUTION in 1 POUCH |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;ORAL | Strength | 7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM | ||||
| Approval Date: | May 4, 2018 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Sep 10, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Mar 25, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Mar 9, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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