Details for New Drug Application (NDA): 216517
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NDA 216517 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 216517
| Tradename: | COLESTIPOL HYDROCHLORIDE |
| Applicant: | Ani Pharms |
| Ingredient: | colestipol hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 216517
| Mechanism of Action | Bile-acid Binding Activity |
Medical Subject Heading (MeSH) Categories for 216517
Suppliers and Packaging for NDA: 216517
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| COLESTIPOL HYDROCHLORIDE | colestipol hydrochloride | TABLET;ORAL | 216517 | ANDA | ANI Pharmaceuticals, Inc. | 62559-395 | 62559-395-12 | 120 TABLET, FILM COATED in 1 BOTTLE (62559-395-12) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1GM | ||||
| Approval Date: | Mar 10, 2023 | TE: | AB | RLD: | No | ||||
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