Details for New Drug Application (NDA): 021881
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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: | 0 |
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 | ||||
Expired US Patents for NDA 021881
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Salix Pharms | MOVIPREP | ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate | FOR SOLUTION;ORAL | 021881-001 | Aug 2, 2006 | ⤷ Get Started Free | ⤷ Get Started Free |
| Salix Pharms | MOVIPREP | ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate | FOR SOLUTION;ORAL | 021881-001 | Aug 2, 2006 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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