Application 212501
- Type
- NDA
- Sponsor
- INGENUS PHARMS LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | INJECTABLE;INJECTION | 500MG/2.5ML | No | No |
| 002 | CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | INJECTABLE;INJECTION | 1G/5ML | No | No |
| 003 | CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | SOLUTION;INTRAVENOUS | 2G/10ML (200MG/ML) | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50742-519 | CYCLOPHOSPHAMIDE | cyclophosphamide | Ingenus Pharmaceuticals, LLC | NDA | Current |
| 50742-519 | CYCLOPHOSPHAMIDE | cyclophosphamide | Ingenus Pharmaceuticals, LLC | NDA | Current |
| 50742-519 | CYCLOPHOSPHAMIDE | cyclophosphamide | Ingenus Pharmaceuticals, LLC | NDA | Current |
| 50742-519 | CYCLOPHOSPHAMIDE | cyclophosphamide | Ingenus Pharmaceuticals, LLC | NDA | Current |
| 50742-519 | CYCLOPHOSPHAMIDE | cyclophosphamide | Ingenus Pharmaceuticals, LLC | NDA | Current |
| 50742-519 | CYCLOPHOSPHAMIDE | cyclophosphamide | Ingenus Pharmaceuticals, LLC | NDA | Current |
| 50742-520 | CYCLOPHOSPHAMIDE | cyclophosphamide | Ingenus Pharmaceuticals, LLC | NDA | Current |
| 50742-520 | CYCLOPHOSPHAMIDE | cyclophosphamide | Ingenus Pharmaceuticals, LLC | NDA | Current |
| 50742-520 | CYCLOPHOSPHAMIDE | cyclophosphamide | Ingenus Pharmaceuticals, LLC | NDA | Current |
| 50742-520 | CYCLOPHOSPHAMIDE | cyclophosphamide | Ingenus Pharmaceuticals, LLC | NDA | Current |
| 50742-520 | CYCLOPHOSPHAMIDE | cyclophosphamide | Ingenus Pharmaceuticals, LLC | NDA | Current |
| 50742-520 | CYCLOPHOSPHAMIDE | cyclophosphamide | Ingenus Pharmaceuticals, LLC | NDA | Current |
| 50742-521 | CYCLOPHOSPHAMIDE | cyclophosphamide | Ingenus Pharmaceuticals, LLC | NDA | Current |
| 50742-521 | CYCLOPHOSPHAMIDE | cyclophosphamide | Ingenus Pharmaceuticals, LLC | NDA | Current |
| 50742-521 | CYCLOPHOSPHAMIDE | cyclophosphamide | Ingenus Pharmaceuticals, LLC | NDA | Current |
| 68001-563 | CYCLOPHOSPHAMIDE | cyclophosphamide | BluePoint Laboratories | NDA | Current |
| 68001-564 | CYCLOPHOSPHAMIDE | cyclophosphamide | BluePoint Laboratories | NDA | Current |
| 68001-565 | CYCLOPHOSPHAMIDE | cyclophosphamide | BluePoint Laboratories | NDA | Current |
| 70860-218 | Cyclophosphamide | cyclophosphamide | Athenex Pharmaceutical Division, LLC. | NDA | Current |
| 70860-218 | Cyclophosphamide | cyclophosphamide | Athenex Pharmaceutical Division, LLC. | NDA | Current |
| 70860-218 | Cyclophosphamide | cyclophosphamide | Athenex Pharmaceutical Division, LLC. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 81573 | SUPPL | 2025-03-14 |
| 81549 | SUPPL | 2025-03-13 |
| 78939 | SUPPL | 2024-07-01 |
| 78902 | SUPPL | 2024-06-26 |
| 68589 | SUPPL | 2021-09-13 |
| 68573 | SUPPL | 2021-09-10 |
| 68081 | ORIG | 2021-07-14 |
| 64180 | ORIG | 2020-08-03 |
| 64161 | ORIG | 2020-07-31 |