Details for New Drug Application (NDA): 016949
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The generic ingredient in LIMBITROL DS 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 016949
Tradename: | LIMBITROL DS |
Applicant: | Chartwell Rx |
Ingredient: | amitriptyline hydrochloride; chlordiazepoxide |
Patents: | 0 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 12.5MG BASE;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 25MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes |
Expired US Patents for NDA 016949
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Chartwell Rx | LIMBITROL | amitriptyline hydrochloride; chlordiazepoxide | TABLET;ORAL | 016949-001 | Approved Prior to Jan 1, 1982 | 4,316,897 | ⤷ Subscribe |
Chartwell Rx | LIMBITROL DS | amitriptyline hydrochloride; chlordiazepoxide | TABLET;ORAL | 016949-002 | Approved Prior to Jan 1, 1982 | 4,316,897 | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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