FdaApplication
NDA 018703
Identifiers
- fda_app_no: NDA018703
Properties
| Property | Value |
|---|---|
| applicant_name | GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE |
| application_type | NDA |
| approval_date | 1983-06-09 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ZANTAC 150 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| ZANTAC 300 | RANITIDINE HYDROCHLORIDE | EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
2 products