Application 090270
- Type
- ANDA
- Sponsor
- MYLAN INSTITUTIONAL
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MELPHALAN HYDROCHLORIDE | MELPHALAN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 50MG BASE/VIAL | No | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 67457-195 | Melphalan Hydrochloride | Melphalan Hydrochloride | Mylan Institutional LLC | ANDA | Current |
| 67457-195 | Melphalan Hydrochloride | Melphalan Hydrochloride | Mylan Institutional LLC | ANDA | Current |
| 67457-215 | Melphalan Hydrochloride | Melphalan Hydrochloride | Mylan Institutional LLC | ANDA | Current |
| 67457-215 | Melphalan Hydrochloride | Melphalan Hydrochloride | Mylan Institutional LLC | ANDA | Current |
| 67457-579 | Melphalan Hydrochloride | Melphalan Hydrochloride | Mylan Institutional LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 31460 | ORIG | 2009-06-16 |