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 three suppliers. 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 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 022362
| Mechanism of Action | Bile-acid Binding Activity |
Medical Subject Heading (MeSH) Categories for 022362
Suppliers and Packaging for NDA: 022362
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| WELCHOL | colesevelam hydrochloride | FOR SUSPENSION;ORAL | 022362 | NDA | Cosette Pharmaceuticals, Inc. | 0713-0880 | 0713-0880-30 | 30 PACKET in 1 CARTON (0713-0880-30) / 1 FOR SUSPENSION in 1 PACKET |
| WELCHOL | colesevelam hydrochloride | FOR SUSPENSION;ORAL | 022362 | NDA | Cosette Pharmaceuticals, Inc. | 0713-0935 | 0713-0935-30 | 30 PACKET in 1 CARTON (0713-0935-30) / 1 FOR SUSPENSION in 1 PACKET |
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| FOR SUSPENSION;ORAL | Strength | 1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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 | |||||
| Regulatory Exclusivity Expiration: | Oct 20, 2024 | ||||||||
| Regulatory Exclusivity Use: | INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES | ||||||||
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 | ||||
| Regulatory Exclusivity Expiration: | Oct 20, 2024 | ||||||||
| Regulatory Exclusivity Use: | INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES | ||||||||
Expired US Patents for NDA 022362
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Cosette | WELCHOL | colesevelam hydrochloride | FOR SUSPENSION;ORAL | 022362-001 | Oct 2, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Cosette | WELCHOL | colesevelam hydrochloride | FOR SUSPENSION;ORAL | 022362-001 | Oct 2, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Cosette | WELCHOL | colesevelam hydrochloride | FOR SUSPENSION;ORAL | 022362-001 | Oct 2, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Cosette | WELCHOL | colesevelam hydrochloride | FOR SUSPENSION;ORAL | 022362-002 | Oct 2, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Cosette | WELCHOL | colesevelam hydrochloride | FOR SUSPENSION;ORAL | 022362-001 | Oct 2, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Cosette | WELCHOL | colesevelam hydrochloride | FOR SUSPENSION;ORAL | 022362-001 | Oct 2, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Cosette | WELCHOL | colesevelam hydrochloride | FOR SUSPENSION;ORAL | 022362-002 | Oct 2, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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