Details for New Drug Application (NDA): 091600
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NDA 091600 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 thirteen 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. Fifteen 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. Fifteen suppliers are listed for this compound. Additional details are available on the colesevelam hydrochloride profile page.
Summary for 091600
| Tradename: | COLESEVELAM HYDROCHLORIDE |
| Applicant: | Impax Labs Inc |
| Ingredient: | colesevelam hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 091600
| Mechanism of Action | Bile-acid Binding Activity |
Medical Subject Heading (MeSH) Categories for 091600
Suppliers and Packaging for NDA: 091600
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| COLESEVELAM HYDROCHLORIDE | colesevelam hydrochloride | TABLET;ORAL | 091600 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-1320 | 0115-1320-19 | 180 TABLET, COATED in 1 BOTTLE (0115-1320-19) |
| COLESEVELAM HYDROCHLORIDE | colesevelam hydrochloride | TABLET;ORAL | 091600 | ANDA | American Health Packaging | 60687-385 | 60687-385-25 | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-385-25) / 1 TABLET, COATED in 1 BLISTER PACK (60687-385-95) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 625MG | ||||
| Approval Date: | May 16, 2018 | TE: | AB | RLD: | No | ||||
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