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Application 206775
- Type
- ANDA
- Sponsor
- ACCORD HLTHCARE
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CARBOPLATIN | CARBOPLATIN | INJECTABLE;INTRAVENOUS | 50MG/5ML (10MG/ML) | No | No |
| 002 | CARBOPLATIN | CARBOPLATIN | INJECTABLE;INTRAVENOUS | 150MG/15ML (10MG/ML) | No | No |
| 003 | CARBOPLATIN | CARBOPLATIN | INJECTABLE;INTRAVENOUS | 450MG/45ML (10MG/ML) | No | No |
| 004 | CARBOPLATIN | CARBOPLATIN | INJECTABLE;INTRAVENOUS | 600MG/60ML (10MG/ML) | No | No |
| 005 | CARBOPLATIN | CARBOPLATIN | INJECTABLE;INTRAVENOUS | 1GM/100ML (10MG/ML) | No | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16729-295 | Carboplatin | Carboplatin | Accord Healthcare, Inc. | ANDA | Current |
| 16729-295 | Carboplatin | Carboplatin | Accord Healthcare, Inc. | ANDA | Current |
| 69448-005 | PARAPLATIN | Carboplatin | Accord BioPharma Inc. | ANDA | Current |
| 69448-005 | PARAPLATIN | Carboplatin | Accord BioPharma Inc. | ANDA | Current |
| 69448-005 | PARAPLATIN | Carboplatin | Accord BioPharma Inc. | ANDA | Current |
| 69448-005 | PARAPLATIN | Carboplatin | Accord BioPharma Inc. | ANDA | Current |