Details for New Drug Application (NDA): 203480
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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 203480
Tradename: | COLESEVELAM HYDROCHLORIDE |
Applicant: | Glenmark Pharms Ltd |
Ingredient: | colesevelam hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 203480
Mechanism of Action | Bile-acid Binding Activity |
Medical Subject Heading (MeSH) Categories for 203480
Suppliers and Packaging for NDA: 203480
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
COLESEVELAM HYDROCHLORIDE | colesevelam hydrochloride | TABLET;ORAL | 203480 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-433 | 68462-433-18 | 180 TABLET, FILM COATED in 1 BOTTLE (68462-433-18) |
COLESEVELAM HYDROCHLORIDE | colesevelam hydrochloride | TABLET;ORAL | 203480 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-433 | 68462-433-90 | 90 TABLET, FILM COATED in 1 BOTTLE (68462-433-90) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 625MG | ||||
Approval Date: | May 18, 2018 | TE: | AB | RLD: | No |
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