Details for New Drug Application (NDA): 210316
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NDA 210316 describes COLESEVELAM HYDROCHLORIDE, which is a drug marketed by Alkem Labs Ltd, Glenmark Pharms Ltd, Impax, Watson Labs Inc, Beijing Tide Pharm, Bionpharma, Chartwell Rx, Dr Reddys, Impax Labs Inc, Invagen Pharms, Inventia, United Res Labs, Zhejiang Jingxin, and Zydus Pharms, and is included in seventeen NDAs. It is available from fourteen suppliers. Additional details are available on the COLESEVELAM HYDROCHLORIDE profile page.
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.
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 210316
| Tradename: | COLESEVELAM HYDROCHLORIDE |
| Applicant: | Alkem Labs Ltd |
| Ingredient: | colesevelam hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 210316
| Mechanism of Action | Bile-acid Binding Activity |
Medical Subject Heading (MeSH) Categories for 210316
Suppliers and Packaging for NDA: 210316
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| COLESEVELAM HYDROCHLORIDE | colesevelam hydrochloride | FOR SUSPENSION;ORAL | 210316 | ANDA | Bryant Ranch Prepack | 63629-8860 | 63629-8860-1 | 30 PACKET in 1 CARTON (63629-8860-1) / 1 POWDER, FOR SUSPENSION in 1 PACKET |
| COLESEVELAM HYDROCHLORIDE | colesevelam hydrochloride | FOR SUSPENSION;ORAL | 210316 | ANDA | Ascend Laboratories, LLC | 67877-523 | 67877-523-30 | 30 POWDER, FOR SUSPENSION in 1 PACKET (67877-523-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 3.75GM/PACKET | ||||
| Approval Date: | May 6, 2019 | TE: | AB | RLD: | No | ||||
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