Details for New Drug Application (NDA): 212886
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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 212886
Tradename: | COLESEVELAM HYDROCHLORIDE |
Applicant: | Impax |
Ingredient: | colesevelam hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 212886
Mechanism of Action | Bile-acid Binding Activity |
Medical Subject Heading (MeSH) Categories for 212886
Suppliers and Packaging for NDA: 212886
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
COLESEVELAM HYDROCHLORIDE | colesevelam hydrochloride | FOR SUSPENSION;ORAL | 212886 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-1864 | 0115-1864-18 | 30 PACKET in 1 CARTON (0115-1864-18) / 1 FOR SUSPENSION in 1 PACKET (0115-1864-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | FOR SUSPENSION;ORAL | Strength | 3.75GM/PACKET | ||||
Approval Date: | Jan 18, 2023 | TE: | RLD: | No |
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