Details for New Drug Application (NDA): 085475
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NDA 085475 describes LIBRIUM, which is a drug marketed by Bausch and Valeant Pharm Intl and is included in five NDAs. It is available from two suppliers. Additional details are available on the LIBRIUM profile page.
The generic ingredient in LIBRIUM is chlordiazepoxide hydrochloride. There are nine drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the chlordiazepoxide hydrochloride profile page.
The generic ingredient in LIBRIUM is chlordiazepoxide hydrochloride. There are nine drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the chlordiazepoxide hydrochloride profile page.
Summary for 085475
| Tradename: | LIBRIUM |
| Applicant: | Bausch |
| Ingredient: | chlordiazepoxide hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 085475
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LIBRIUM | chlordiazepoxide hydrochloride | CAPSULE;ORAL | 085475 | ANDA | Epic Pharma LLC | 42806-563 | 42806-563-01 | 100 CAPSULE, GELATIN COATED in 1 BOTTLE (42806-563-01) |
| LIBRIUM | chlordiazepoxide hydrochloride | CAPSULE;ORAL | 085475 | ANDA | Epic Pharma, LLC | 42806-566 | 42806-566-01 | 100 CAPSULE, GELATIN COATED in 1 BOTTLE (42806-566-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
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