Application 207793
- Type
- NDA
- Sponsor
- IPSEN INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ONIVYDE | IRINOTECAN HYDROCHLORIDE | INJECTABLE, LIPOSOMAL;INTRAVENOUS | EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML) | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 15054-0043 | Onivyde | IRINOTECAN HYDROCHLORIDE | Ipsen Biopharmaceuticals, Inc. | NDA | Current |
| 15054-0043 | Onivyde | IRINOTECAN HYDROCHLORIDE | Ipsen Biopharmaceuticals, Inc. | NDA | Current |
| 69171-398 | Onivyde | Irinotecan hydrochloride | Merrimack Pharmaceuticals | NDA | Current |