Details for New Drug Application (NDA): 022362
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NDA 022362 describes WELCHOL, which is a drug marketed by Cosette and is included in four NDAs. It is available from one supplier. Additional details are available on the WELCHOL profile page.
The generic ingredient in WELCHOL is colesevelam hydrochloride. There are ten drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the colesevelam hydrochloride profile page.
The generic ingredient in WELCHOL is colesevelam hydrochloride. There are ten drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the colesevelam hydrochloride profile page.
Summary for 022362
| Tradename: | WELCHOL |
| Applicant: | Cosette |
| Ingredient: | colesevelam hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 022362
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | FOR SUSPENSION;ORAL | Strength | 1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Oct 2, 2009 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 3.75GM/PACKET | ||||
| Approval Date: | Oct 2, 2009 | TE: | AB | RLD: | Yes | ||||
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