Details for New Drug Application (NDA): 215223
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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 215223
Tradename: | COLESTIPOL HYDROCHLORIDE |
Applicant: | Zydus Pharms |
Ingredient: | colestipol hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 215223
Mechanism of Action | Bile-acid Binding Activity |
Medical Subject Heading (MeSH) Categories for 215223
Suppliers and Packaging for NDA: 215223
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
COLESTIPOL HYDROCHLORIDE | colestipol hydrochloride | TABLET;ORAL | 215223 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1467 | 70710-1467-5 | 500 TABLET, FILM COATED in 1 BOTTLE (70710-1467-5) |
COLESTIPOL HYDROCHLORIDE | colestipol hydrochloride | TABLET;ORAL | 215223 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1467 | 70710-1467-7 | 120 TABLET, FILM COATED in 1 BOTTLE (70710-1467-7) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1GM | ||||
Approval Date: | Mar 10, 2022 | TE: | AB | RLD: | No |
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