Details for New Drug Application (NDA): 209946
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NDA 209946 describes COLESEVELAM HYDROCHLORIDE, which is a drug marketed by Alkem Labs Ltd, Glenmark Pharms Ltd, Impax, Watson Labs Inc, Beijing Tide Pharm, Bionpharma, Chartwell Rx, Dr Reddys, Impax Labs Inc, Invagen Pharms, Inventia, United Res Labs, Zhejiang Jingxin, and Zydus Pharms, and is included in seventeen NDAs. It is available from fourteen suppliers. Additional details are available on the COLESEVELAM HYDROCHLORIDE profile page.
The generic ingredient in COLESEVELAM HYDROCHLORIDE 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.
The generic ingredient in COLESEVELAM HYDROCHLORIDE 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 209946
| Tradename: | COLESEVELAM HYDROCHLORIDE |
| Applicant: | Zhejiang Jingxin |
| Ingredient: | colesevelam hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 209946
| Mechanism of Action | Bile-acid Binding Activity |
Medical Subject Heading (MeSH) Categories for 209946
Suppliers and Packaging for NDA: 209946
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| COLESEVELAM HYDROCHLORIDE | colesevelam hydrochloride | TABLET;ORAL | 209946 | ANDA | Tris Pharma Inc | 27808-190 | 27808-190-01 | 180 TABLET in 1 BOTTLE (27808-190-01) |
| COLESEVELAM HYDROCHLORIDE | colesevelam hydrochloride | TABLET;ORAL | 209946 | ANDA | Golden State Medical Supply, Inc. | 51407-336 | 51407-336-18 | 180 TABLET in 1 BOTTLE (51407-336-18) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 625MG | ||||
| Approval Date: | Jul 15, 2020 | TE: | AB | RLD: | No | ||||
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