Details for New Drug Application (NDA): 022362
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The generic ingredient in WELCHOL is colesevelam hydrochloride. There are ten drug master file entries for this compound. Sixteen 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 |
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| FOR SUSPENSION;ORAL | Strength | 1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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 | ⤷ Sign Up | ⤷ Sign Up |
Cosette | WELCHOL | colesevelam hydrochloride | FOR SUSPENSION;ORAL | 022362-002 | Oct 2, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Cosette | WELCHOL | colesevelam hydrochloride | FOR SUSPENSION;ORAL | 022362-001 | Oct 2, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Cosette | WELCHOL | colesevelam hydrochloride | FOR SUSPENSION;ORAL | 022362-002 | Oct 2, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Cosette | WELCHOL | colesevelam hydrochloride | FOR SUSPENSION;ORAL | 022362-002 | Oct 2, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Cosette | WELCHOL | colesevelam hydrochloride | FOR SUSPENSION;ORAL | 022362-002 | Oct 2, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Cosette | WELCHOL | colesevelam hydrochloride | FOR SUSPENSION;ORAL | 022362-002 | Oct 2, 2009 | ⤷ Sign Up | ⤷ Sign Up |
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