Application 215636
- Type
- ANDA
- Sponsor
- ZYDUS LIFESCIENCES
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | METHYLENE BLUE | METHYLENE BLUE | SOLUTION;INTRAVENOUS | 10MG/2ML (5MG/ML) | No | No |
| 002 | METHYLENE BLUE | METHYLENE BLUE | SOLUTION;INTRAVENOUS | 50MG/10ML (5MG/ML) | No | No |
| 003 | METHYLENE BLUE | METHYLENE BLUE | SOLUTION;INTRAVENOUS | 5MG/ML (5MG/ML) | No | Yes |
| 004 | METHYLENE BLUE | METHYLENE BLUE | SOLUTION;INTRAVENOUS | 100MG/10ML (10MG/ML) | No | Yes |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 77370 | ORIG | 2024-01-31 |