Skip to contentApplication 078589
- Type
- ANDA
- Sponsor
- ACTAVIS TOTOWA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | IRINOTECAN HYDROCHLORIDE | IRINOTECAN HYDROCHLORIDE | INJECTABLE;INJECTION | 40MG/2ML (20MG/ML) | No | No |
| 002 | IRINOTECAN HYDROCHLORIDE | IRINOTECAN HYDROCHLORIDE | INJECTABLE;INJECTION | 100MG/5ML (20MG/ML) | No | No |
| 003 | IRINOTECAN HYDROCHLORIDE | IRINOTECAN HYDROCHLORIDE | INJECTABLE;INJECTION | 500MG/25ML (20MG/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 45963-614 | Irinotecan hydrochloride | Irinotecan hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 45963-614 | Irinotecan hydrochloride | Irinotecan hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 45963-614 | Irinotecan hydrochloride | Irinotecan hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 45963-614 | Irinotecan hydrochloride | Irinotecan hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 45963-614 | Irinotecan hydrochloride | Irinotecan hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 45963-614 | Irinotecan hydrochloride | Irinotecan hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 45963-614 | Irinotecan hydrochloride | Irinotecan hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 45963-614 | Irinotecan hydrochloride | Irinotecan hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 45963-614 | Irinotecan hydrochloride | Irinotecan hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 45963-614 | Irinotecan hydrochloride | Irinotecan hydrochloride | Actavis Pharma, Inc. | ANDA | Current |