Application 077219
- Type
- ANDA
- Sponsor
- CIPLA LTD
Application Products#
| 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 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16714-725 | Irinotecan Hydrochloride | Irinotecan Hydrochloride | NorthStar RxLLC | ANDA | Current |
| 16714-725 | Irinotecan Hydrochloride | Irinotecan Hydrochloride | NorthStar RxLLC | ANDA | Current |
| 16714-726 | Irinotecan Hydrochloride | Irinotecan Hydrochloride | NorthStar RxLLC | ANDA | Current |
| 16714-726 | Irinotecan Hydrochloride | Irinotecan Hydrochloride | NorthStar RxLLC | ANDA | Current |
| 59923-702 | Irinotecan Hydrochloride | Irinotecan Hydrochloride | Areva Pharmaceuticals,Inc | ANDA | Current |
| 59923-702 | Irinotecan Hydrochloride | Irinotecan Hydrochloride | Areva Pharmaceuticals,Inc. | ANDA | Current |
| 68001-284 | Irinotecan Hydrochloride | Irinotecan Hydrochloride | BluePoint Laboratories | ANDA | Current |
| 68001-284 | Irinotecan Hydrochloride | Irinotecan Hydrochloride | BluePoint Laboratories | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31207 | ORIG | 2008-02-22 |