Application 090643
- Type
- ANDA
- Sponsor
- MYLAN INSTITUTIONAL
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | IBUTILIDE FUMARATE | IBUTILIDE FUMARATE | INJECTABLE;INJECTION | 0.1MG/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 67457-366 | Ibutilide Fumarate | Ibutilide Fumarate | Mylan Institutional LLC | ANDA | Current |
| 67457-366 | Ibutilide Fumarate | Ibutilide Fumarate | Mylan Institutional LLC | ANDA | Current |
| 67457-366 | Ibutilide Fumarate | Ibutilide Fumarate | Mylan Institutional LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 31483 | ORIG | 2010-01-15 |