Application 208718
- Type
- ANDA
- Sponsor
- SHILPA MEDICARE LTD
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 | 300MG/15ML (20MG/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 59923-714 | Irinotecan Hydrochloride | Irinotecan Hydrochloride | Areva Pharmaceuticals, Inc. | ANDA | Current |
| 59923-714 | Irinotecan Hydrochloride | Irinotecan Hydrochloride | Areva Pharmaceuticals, Inc. | ANDA | Current |
| 59923-714 | Irinotecan Hydrochloride | Irinotecan Hydrochloride | Areva Pharmaceuticals, Inc. | ANDA | Current |
| 59923-714 | Irinotecan Hydrochloride | Irinotecan Hydrochloride | Areva Pharmaceuticals, Inc. | ANDA | Current |
| 59923-714 | Irinotecan Hydrochloride | Irinotecan Hydrochloride | Areva Pharmaceuticals, Inc. | ANDA | Current |
| 59923-715 | Irinotecan Hydrochloride | Irinotecan Hydrochloride | Areva Pharmaceuticals, Inc. | ANDA | Current |
| 59923-715 | Irinotecan Hydrochloride | Irinotecan Hydrochloride | Areva Pharmaceuticals, Inc. | ANDA | Current |
| 59923-715 | Irinotecan Hydrochloride | Irinotecan Hydrochloride | Areva Pharmaceuticals, Inc. | ANDA | Current |
| 59923-715 | Irinotecan Hydrochloride | Irinotecan Hydrochloride | Areva Pharmaceuticals, Inc. | ANDA | Current |
| 59923-715 | Irinotecan Hydrochloride | Irinotecan Hydrochloride | Areva Pharmaceuticals, Inc. | ANDA | Current |
| 59923-716 | Irinotecan Hydrochloride | Irinotecan Hydrochloride | Areva Pharmaceuticals, Inc. | ANDA | Current |
| 59923-716 | Irinotecan Hydrochloride | Irinotecan Hydrochloride | Areva Pharmaceuticals, Inc. | ANDA | Current |
| 59923-716 | Irinotecan Hydrochloride | Irinotecan Hydrochloride | Areva Pharmaceuticals, Inc. | ANDA | Current |
| 59923-716 | Irinotecan Hydrochloride | Irinotecan Hydrochloride | Areva Pharmaceuticals, Inc. | ANDA | Current |
| 68001-425 | Irinotecan Hydrochloride | Irinotecan Hydrochloride | BluePoint Laboratories | ANDA | Current |
| 68001-426 | Irinotecan Hydrochloride | Irinotecan Hydrochloride | BluePoint Laboratories | ANDA | Current |
| 72485-211 | Irinotecan Hydrochloride | Irinotecan Hydrochloride | Armas Pharmaceuticals Inc. | ANDA | Current |
| 72485-211 | Irinotecan Hydrochloride | Irinotecan Hydrochloride | Armas Pharmacueticals Inc | ANDA | Current |
| 72485-212 | Irinotecan Hydrochloride | Irinotecan Hydrochloride | Armas Pharmacueticals Inc | ANDA | Current |
| 72485-212 | Irinotecan Hydrochloride | Irinotecan Hydrochloride | Armas Pharmaceuticals Inc. | ANDA | Current |
| 72485-213 | Irinotecan Hydrochloride | Irinotecan Hydrochloride | Armas Pharmaceuticals Inc. | ANDA | Current |