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Details for New Drug Application (NDA): 071297
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 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 071297
Ingredient-type | Benzodiazepines |
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 | N | 0378-0211-01 |
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE | amitriptyline hydrochloride; chlordiazepoxide | TABLET;ORAL | 071297 | ANDA | Mylan Pharmaceuticals Inc. | 0378-0211 | N | 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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