Details for New Drug Application (NDA): 207765
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The generic ingredient in COLESEVELAM HYDROCHLORIDE is colesevelam hydrochloride. There are ten drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the colesevelam hydrochloride profile page.
Summary for 207765
Tradename: | COLESEVELAM HYDROCHLORIDE |
Applicant: | Zydus Pharms |
Ingredient: | colesevelam hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 207765
Mechanism of Action | Bile-acid Binding Activity |
Medical Subject Heading (MeSH) Categories for 207765
Suppliers and Packaging for NDA: 207765
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
COLESEVELAM HYDROCHLORIDE | colesevelam hydrochloride | TABLET;ORAL | 207765 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-619 | 68382-619-10 | 1000 TABLET, FILM COATED in 1 BOTTLE (68382-619-10) |
COLESEVELAM HYDROCHLORIDE | colesevelam hydrochloride | TABLET;ORAL | 207765 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-619 | 68382-619-28 | 180 TABLET, FILM COATED in 1 BOTTLE (68382-619-28) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 625MG | ||||
Approval Date: | Oct 7, 2019 | TE: | AB | RLD: | No |
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