Details for New Drug Application (NDA): 083116
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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. Fifteen suppliers are listed for this compound. Additional details are available on the chlordiazepoxide hydrochloride; clidinium bromide profile page.
Summary for 083116
Tradename: | CHLORDIAZEPOXIDE HYDROCHLORIDE |
Applicant: | Barr |
Ingredient: | chlordiazepoxide hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 083116
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CHLORDIAZEPOXIDE HYDROCHLORIDE | chlordiazepoxide hydrochloride | CAPSULE;ORAL | 083116 | ANDA | Teva Pharmaceuticals USA, Inc. | 0555-0033 | 0555-0033-02 | 100 CAPSULE in 1 BOTTLE (0555-0033-02) |
CHLORDIAZEPOXIDE HYDROCHLORIDE | chlordiazepoxide hydrochloride | CAPSULE;ORAL | 083116 | ANDA | Teva Pharmaceuticals USA, Inc. | 0555-0033 | 0555-0033-05 | 1000 CAPSULE in 1 BOTTLE (0555-0033-05) |
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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