Details for New Drug Application (NDA): 077277
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NDA 077277 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 077277
| Tradename: | COLESTIPOL HYDROCHLORIDE |
| Applicant: | Impax Labs |
| Ingredient: | colestipol hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 077277
| Mechanism of Action | Bile-acid Binding Activity |
Medical Subject Heading (MeSH) Categories for 077277
Suppliers and Packaging for NDA: 077277
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| COLESTIPOL HYDROCHLORIDE | colestipol hydrochloride | GRANULE;ORAL | 077277 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-5212 | 0115-5212-18 | 30 SUSPENSION in 1 CARTON (0115-5212-18) |
| COLESTIPOL HYDROCHLORIDE | colestipol hydrochloride | GRANULE;ORAL | 077277 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-5212 | 0115-5212-29 | 90 SUSPENSION in 1 CARTON (0115-5212-29) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GRANULE;ORAL | Strength | 5GM/SCOOPFUL | ||||
| Approval Date: | May 2, 2006 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | GRANULE;ORAL | Strength | 5GM/PACKET | ||||
| Approval Date: | May 2, 2006 | TE: | AB | RLD: | No | ||||
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