Details for New Drug Application (NDA): 083116
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NDA 083116 describes CHLORDIAZEPOXIDE HYDROCHLORIDE, which is a drug marketed by Ascot, Barr, Chartwell Rx, Ferrante, Halsey, Impax Labs, Ivax Sub Teva Pharms, Lederle, Mast Mm, Mylan, Parke Davis, Pioneer Pharms, Purepac Pharm, Roxane, Superpharm, Teva, Upsher Smith Labs, Usl Pharma, Vangard, Watson Labs, West Ward, Alembic, Alkem Labs Ltd, Amneal, Aurobindo Pharma Ltd, Corepharma, Dr Reddys, Micro Labs, Misemer, Nuvo Pharms Inc, Teva Pharms Usa, Torrent, and Winder Labs Llc, and is included in seventy-seven NDAs. It is available from eleven suppliers. Additional details are available on the CHLORDIAZEPOXIDE HYDROCHLORIDE profile page.
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.
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 |
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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