Details for New Drug Application (NDA): 204893
NDA 204893 describes COLESEVELAM HYDROCHLORIDE, which is a drug marketed by Alkem Labs Ltd, Glenmark Pharms Ltd, Impax, Watson Labs Inc, Adaptis, Beijing Tide Pharm, Bionpharma, Chartwell Rx, Dr Reddys, Impax Labs Inc, Invagen Pharms, Macleods Pharms, United Res Labs, Zhejiang Jingxin, and Zydus Pharms, and is included in eighteen NDAs. It is available from fifteen suppliers. Additional details are available on the COLESEVELAM HYDROCHLORIDE profile page.
The generic ingredient in COLESEVELAM HYDROCHLORIDE is colesevelam hydrochloride. There is one drug master file entry for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the colesevelam hydrochloride profile page.
The generic ingredient in COLESEVELAM HYDROCHLORIDE is colesevelam hydrochloride. There is one drug master file entry for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the colesevelam hydrochloride profile page.
Summary for 204893
| Tradename: | COLESEVELAM HYDROCHLORIDE |
| Applicant: | Macleods Pharms |
| Ingredient: | colesevelam hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 204893
| Mechanism of Action | Bile-acid Binding Activity |
Medical Subject Heading (MeSH) Categories for 204893
Suppliers and Packaging for NDA: 204893
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| COLESEVELAM HYDROCHLORIDE | colesevelam hydrochloride | TABLET;ORAL | 204893 | ANDA | Macleods Pharmaceuticals Limited | 33342-197 | 33342-197-57 | 180 TABLET, FILM COATED in 1 BOTTLE (33342-197-57) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 625MG | ||||
| Approval Date: | Apr 18, 2025 | TE: | RLD: | No | |||||
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