Details for New Drug Application (NDA): 217667
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NDA 217667 describes COLESTIPOL HYDROCHLORIDE, which is a drug marketed by Impax Labs, Ani Pharms, Edenbridge Pharms, and Zydus Pharms, and is included in five NDAs. It is available from six suppliers. Additional details are available on the COLESTIPOL HYDROCHLORIDE profile page.
The generic ingredient in COLESTIPOL HYDROCHLORIDE is colestipol hydrochloride. There are two drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the colestipol hydrochloride profile page.
The generic ingredient in COLESTIPOL HYDROCHLORIDE is colestipol hydrochloride. There are two drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the colestipol hydrochloride profile page.
Summary for 217667
| Tradename: | COLESTIPOL HYDROCHLORIDE |
| Applicant: | Edenbridge Pharms |
| Ingredient: | colestipol hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 217667
| Mechanism of Action | Bile-acid Binding Activity |
Medical Subject Heading (MeSH) Categories for 217667
Suppliers and Packaging for NDA: 217667
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| COLESTIPOL HYDROCHLORIDE | colestipol hydrochloride | TABLET;ORAL | 217667 | ANDA | Edenbridge Pharmaceuticals LLC. | 42799-115 | 42799-115-01 | 120 TABLET in 1 BOTTLE (42799-115-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1GM | ||||
| Approval Date: | Aug 16, 2024 | TE: | AB | RLD: | No | ||||
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