Details for New Drug Application (NDA): 021176
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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 021176
Tradename: | WELCHOL |
Applicant: | Cosette |
Ingredient: | colesevelam hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 021176
Mechanism of Action | Bile-acid Binding Activity |
Medical Subject Heading (MeSH) Categories for 021176
Suppliers and Packaging for NDA: 021176
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
WELCHOL | colesevelam hydrochloride | TABLET;ORAL | 021176 | NDA | Cosette Pharmaceuticals, Inc. | 0713-0879 | 0713-0879-81 | 180 TABLET, FILM COATED in 1 BOTTLE (0713-0879-81) |
WELCHOL | colesevelam hydrochloride | TABLET;ORAL | 021176 | NDA | Cosette Pharmaceuticals, Inc. | 0713-0936 | 0713-0936-81 | 180 TABLET, FILM COATED in 1 BOTTLE (0713-0936-81) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 625MG | ||||
Approval Date: | May 26, 2000 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 021176
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Cosette | WELCHOL | colesevelam hydrochloride | TABLET;ORAL | 021176-001 | May 26, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Cosette | WELCHOL | colesevelam hydrochloride | TABLET;ORAL | 021176-001 | May 26, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Cosette | WELCHOL | colesevelam hydrochloride | TABLET;ORAL | 021176-001 | May 26, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Cosette | WELCHOL | colesevelam hydrochloride | TABLET;ORAL | 021176-001 | May 26, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Cosette | WELCHOL | colesevelam hydrochloride | TABLET;ORAL | 021176-001 | May 26, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Cosette | WELCHOL | colesevelam hydrochloride | TABLET;ORAL | 021176-001 | May 26, 2000 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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