FdaApplication
NDA 016949
Identifiers
- fda_app_no: NDA016949
Properties
| Property | Value |
|---|---|
| applicant_name | CHARTWELL RX SCIENCES LLC |
| application_type | NDA |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| LIMBITROL | AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE | EQ 12.5MG BASE;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| LIMBITROL DS | AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE | EQ 25MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
2 products