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Application 202259
- Type
- ANDA
- Sponsor
- LUITPOLD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | BUSULFAN | BUSULFAN | INJECTABLE;INJECTION | 6MG/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0517-0920 | N/A | busulfan | American Regent, Inc. | ANDA | Current |
| 0517-0920 | BUSULFAN | BUSULFAN | American Regent, Inc. | ANDA | Current |
| 0517-0920 | N/A | busulfan | American Regent, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 32220 | ORIG | 2015-12-29 |