Application 020745
- Type
- NDA
- Sponsor
- SANOFI US
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZANTAC 75 | RANITIDINE HYDROCHLORIDE | TABLET, EFFERVESCENT;ORAL | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 41639 | ORIG | 2005-05-18 |