Details for New Drug Application (NDA): 216517
NDA 216517 describes COLESTIPOL HYDROCHLORIDE, which is a drug marketed by Impax Labs, Ani Pharms, Edenbridge Pharms, Macleods Pharms, Riconpharma Llc, and Zydus Pharms, and is included in seven NDAs. It is available from eight suppliers. Additional details are available on the COLESTIPOL HYDROCHLORIDE profile page.
The generic ingredient in COLESTIPOL HYDROCHLORIDE is colestipol hydrochloride. There is one drug master file entry for this compound. Ten 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 is one drug master file entry for this compound. Ten 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) |
| COLESTIPOL HYDROCHLORIDE | colestipol hydrochloride | TABLET;ORAL | 216517 | ANDA | NorthStar Rx LLC | 72603-817 | 72603-817-01 | 120 TABLET, FILM COATED in 1 BOTTLE (72603-817-01) |
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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