Application 207563
- Type
- ANDA
- Sponsor
- INGENUS PHARMS LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DOCETAXEL | DOCETAXEL | INJECTABLE;INJECTION | 20MG/2ML (10MG/ML) | No | No |
| 002 | DOCETAXEL | DOCETAXEL | INJECTABLE;INJECTION | 80MG/8ML (10MG/ML) | No | No |
| 003 | DOCETAXEL | DOCETAXEL | INJECTABLE;INJECTION | 160MG/16ML (10MG/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50742-428 | DOCETAXEL | DOCETAXEL ANHYDROUS | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-428 | DOCETAXEL | DOCETAXEL ANHYDROUS | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-428 | DOCETAXEL | DOCETAXEL ANHYDROUS | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-428 | DOCETAXEL | DOCETAXEL ANHYDROUS | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-431 | DOCETAXEL | DOCETAXEL ANHYDROUS | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-431 | DOCETAXEL | DOCETAXEL ANHYDROUS | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-431 | DOCETAXEL | DOCETAXEL ANHYDROUS | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-431 | DOCETAXEL | DOCETAXEL ANHYDROUS | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-431 | DOCETAXEL | DOCETAXEL ANHYDROUS | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-431 | DOCETAXEL | DOCETAXEL ANHYDROUS | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-463 | DOCETAXEL | DOCETAXEL ANHYDROUS | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-463 | DOCETAXEL | DOCETAXEL ANHYDROUS | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-463 | DOCETAXEL | DOCETAXEL ANHYDROUS | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-463 | DOCETAXEL | DOCETAXEL ANHYDROUS | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-463 | DOCETAXEL | DOCETAXEL ANHYDROUS | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-463 | DOCETAXEL | DOCETAXEL ANHYDROUS | Ingenus Pharmaceuticals, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 49686 | ORIG | 2017-09-07 |