FdaApplication
NDA 020648
Identifiers
- fda_app_no: NDA020648
Properties
| Property | Value |
|---|---|
| applicant_name | BAUSCH HEALTH US LLC |
| application_type | NDA |
| approval_date | 1997-07-29 |
Products (7)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| DIASTAT | DIAZEPAM | 2.5MG/0.5ML (5MG/ML) | GEL;RECTAL |
| DIASTAT | DIAZEPAM | 15MG/3ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL;RECTAL |
| DIASTAT | DIAZEPAM | 5MG/ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL;RECTAL |
| DIASTAT | DIAZEPAM | 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL;RECTAL |
| DIASTAT | DIAZEPAM | 20MG/4ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL;RECTAL |
| DIASTAT ACUDIAL | DIAZEPAM | 10MG/2ML (5MG/ML) | GEL;RECTAL |
| DIASTAT ACUDIAL | DIAZEPAM | 20MG/4ML (5MG/ML) | GEL;RECTAL |
7 products