Details for New Drug Application (NDA): 084041
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The generic ingredient in CHLORDIAZEPOXIDE HYDROCHLORIDE is chlordiazepoxide hydrochloride; clidinium bromide. 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; clidinium bromide profile page.
Summary for 084041
Tradename: | CHLORDIAZEPOXIDE HYDROCHLORIDE |
Applicant: | Chartwell Rx |
Ingredient: | chlordiazepoxide hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 084041
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CHLORDIAZEPOXIDE HYDROCHLORIDE | chlordiazepoxide hydrochloride | CAPSULE;ORAL | 084041 | ANDA | Chartwell RX, LLC | 62135-221 | 62135-221-60 | 60 CAPSULE in 1 BOTTLE (62135-221-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 10MG | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | No |
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