Application 090874
- Type
- ANDA
- Sponsor
- MYLAN INSTITUTIONAL
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ISOSULFAN BLUE | ISOSULFAN BLUE | INJECTABLE;INJECTION | 1% | No | Yes |
| 002 | ISOSULFAN BLUE | ISOSULFAN BLUE | SOLUTION;SUBCUTANEOUS | 10MG/ML (10MG/ML) | No | Yes |
| 003 | ISOSULFAN BLUE | ISOSULFAN BLUE | SOLUTION;SUBCUTANEOUS | 30MG/3ML (10MG/ML) | No | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 67457-220 | Isosulfan Blue | Isosulfan Blue | Mylan Institutional LLC | ANDA | Current |
| 67457-220 | Isosulfan Blue | Isosulfan Blue | Mylan Institutional LLC | ANDA | Current |
| 67457-586 | Isosulfan Blue | Isosulfan Blue | Mylan Institutional LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 9303 | ORIG | 2010-07-27 |