Details for New Drug Application (NDA): 071297
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NDA 071297 describes CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE, which is a drug marketed by Anda Repository, Chartwell Rx, Heritage Pharma, Micro Labs, Mylan Pharms Inc, Tp Anda Holdings, and Usl Pharma, and is included in ten NDAs. It is available from two suppliers. Additional details are available on the CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE profile page.
The generic ingredient in CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE is amitriptyline hydrochloride; chlordiazepoxide. There are thirteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the amitriptyline hydrochloride; chlordiazepoxide profile page.
The generic ingredient in CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE is amitriptyline hydrochloride; chlordiazepoxide. There are thirteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the amitriptyline hydrochloride; chlordiazepoxide profile page.
Summary for 071297
| Tradename: | CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE |
| Applicant: | Mylan Pharms Inc |
| Ingredient: | amitriptyline hydrochloride; chlordiazepoxide |
| Patents: | 0 |
Suppliers and Packaging for NDA: 071297
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE | amitriptyline hydrochloride; chlordiazepoxide | TABLET;ORAL | 071297 | ANDA | Mylan Pharmaceuticals Inc. | 0378-0211 | 0378-0211-01 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0211-01) |
| CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE | amitriptyline hydrochloride; chlordiazepoxide | TABLET;ORAL | 071297 | ANDA | Mylan Pharmaceuticals Inc. | 0378-0211 | 0378-0211-05 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0211-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 25MG BASE;10MG | ||||
| Approval Date: | Dec 10, 1986 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 12.5MG BASE;5MG | ||||
| Approval Date: | Dec 10, 1986 | TE: | RLD: | No | |||||
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