Details for New Drug Application (NDA): 085475
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The generic ingredient in LIBRIUM is chlordiazepoxide hydrochloride. There are nine drug master file entries for this compound. Fourteen 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 |
Formulation / Manufacturing: | see details |
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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