Details for New Drug Application (NDA): 202190
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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 202190
Tradename: | COLESEVELAM HYDROCHLORIDE |
Applicant: | Glenmark Pharms Ltd |
Ingredient: | colesevelam hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 202190
Mechanism of Action | Bile-acid Binding Activity |
Medical Subject Heading (MeSH) Categories for 202190
Suppliers and Packaging for NDA: 202190
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
COLESEVELAM HYDROCHLORIDE | colesevelam hydrochloride | FOR SUSPENSION;ORAL | 202190 | ANDA | Glenmark Pharmaceuticals Inc.,USA | 68462-620 | 68462-620-30 | 30 PACKET in 1 BOX (68462-620-30) / 1 POWDER, FOR SUSPENSION in 1 PACKET |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 1.875GM/PACKET | ||||
Approval Date: | Jul 16, 2018 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 3.75GM/PACKET | ||||
Approval Date: | Jul 16, 2018 | TE: | AB | RLD: | No |
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