Details for New Drug Application (NDA): 021881
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NDA 021881 describes MOVIPREP, which is a drug marketed by Salix Pharms and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the MOVIPREP profile page.
The generic ingredient in MOVIPREP 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 MOVIPREP 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 021881
| Tradename: | MOVIPREP |
| Applicant: | Salix Pharms |
| Ingredient: | ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate |
| Patents: | 2 |
Suppliers and Packaging for NDA: 021881
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MOVIPREP | ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate | FOR SOLUTION;ORAL | 021881 | NDA | Salix Pharmaceuticals, Inc. | 65649-201 | 65649-201-75 | 1 KIT in 1 CONTAINER (65649-201-75) * 1 L in 1 POUCH * 1 L in 1 POUCH |
| MOVIPREP | ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate | FOR SOLUTION;ORAL | 021881 | NDA | Salix Pharmaceuticals, Inc. | 65649-201 | 65649-201-76 | 1 KIT in 1 CONTAINER (65649-201-76) * 1 L in 1 POUCH * 1 L in 1 POUCH |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;ORAL | Strength | 4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM | ||||
| Approval Date: | Aug 2, 2006 | TE: | AA | RLD: | Yes | ||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Sep 1, 2024 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | ⤷ Try a Trial | Patent Expiration: | Sep 1, 2024 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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