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Application 219935
- Type
- NDA
- Sponsor
- SAGENT
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FAMOTIDINE | FAMOTIDINE | SOLUTION;INTRAVENOUS | 20MG/5ML (4MG/ML) | Yes | Yes |
| 002 | FAMOTIDINE | FAMOTIDINE | SOLUTION;INTRAVENOUS | 40MG/10ML (4MG/ML) | Yes | Yes |
| 003 | FAMOTIDINE | FAMOTIDINE | SOLUTION;INTRAVENOUS | 200MG/50ML (4MG/ML) | Yes | Yes |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 82900 | ORIG | 2025-07-21 |
| 82888 | ORIG | 2025-07-17 |