Application 019434
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | CIMETIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 6MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |