Skip to contentApplication 065003
- Type
- ANDA
- Sponsor
- ABBVIE
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | GENGRAF | CYCLOSPORINE | CAPSULE;ORAL | 25MG | No | No |
| 002 | GENGRAF | CYCLOSPORINE | CAPSULE;ORAL | 50MG | No | No |
| 003 | GENGRAF | CYCLOSPORINE | CAPSULE;ORAL | 100MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0074-3108 | Gengraf | Cyclosporine | AbbVie Inc. | ANDA | Current |
| 0074-3108 | Gengraf | Cyclosporine | AbbVie Inc. | ANDA | Current |
| 0074-3108 | Gengraf | Cyclosporine | AbbVie Inc. | ANDA | Current |
| 0074-3108 | Gengraf | Cyclosporine | AbbVie Inc. | ANDA | Current |
| 0074-3109 | Gengraf | Cyclosporine | AbbVie Inc. | ANDA | Current |
| 0074-3109 | Gengraf | Cyclosporine | AbbVie Inc. | ANDA | Current |
| 0074-3109 | Gengraf | Cyclosporine | AbbVie Inc. | ANDA | Current |
| 0074-3109 | Gengraf | Cyclosporine | AbbVie Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 42799 | ORIG | 2003-07-31 |
| 8364 | ORIG | 2000-05-12 |