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Application 761105
- Type
- BLA
- Sponsor
- ABBVIE INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SKYRIZI | RISANKIZUMAB-RZAA | INJECTABLE;INJECTION | 75MG/0.83ML | No | No |
| 002 | SKYRIZI | RISANKIZUMAB-RZAA | INJECTABLE;INJECTION | 150MG/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0074-1050 | Skyrizi | risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-1050 | Skyrizi | risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-1050 | Skyrizi | risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-1050 | Skyrizi | risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-1050 | Skyrizi | risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-1050 | Skyrizi | risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-1050 | Skyrizi | risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-1050 | Skyrizi | risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-1050 | Skyrizi | risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-1050 | Skyrizi | risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-1050 | Skyrizi | risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-1050 | Skyrizi | risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-1065 | Skyrizi | Risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-1065 | Skyrizi | Risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-1070 | Skyrizi | Risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-1070 | Skyrizi | Risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-1070 | Skyrizi | Risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-1070 | Skyrizi | Risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-1070 | Skyrizi | Risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-1070 | Skyrizi | Risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-1070 | Skyrizi | Risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-2042 | Skyrizi | Risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-2042 | Skyrizi | Risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-2042 | Skyrizi | Risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-2042 | Skyrizi | Risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-2042 | Skyrizi | Risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-2042 | Skyrizi | Risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-2042 | Skyrizi | Risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-2042 | Skyrizi | Risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-2042 | Skyrizi | Risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-2042 | Skyrizi | Risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-2042 | Skyrizi | Risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-2042 | Skyrizi | Risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-2042 | Skyrizi | Risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-2042 | Skyrizi | Risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-2042 | Skyrizi | Risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-2042 | Skyrizi | Risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-2042 | Skyrizi | Risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-2042 | Skyrizi | Risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-2042 | Skyrizi | Risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-2100 | Skyrizi | risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-2100 | Skyrizi | risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-2100 | Skyrizi | risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-2100 | Skyrizi | risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-2100 | Skyrizi | risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-2100 | Skyrizi | risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-2100 | Skyrizi | risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-2100 | Skyrizi | risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-2100 | Skyrizi | risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-2100 | Skyrizi | risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-2100 | Skyrizi | risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-2100 | Skyrizi | risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-5015 | Skyrizi | risankizumab-rzaa | AbbVie Inc. | BLA | Current |
| 0074-5015 | Skyrizi | risankizumab-rzaa | AbbVie Inc. | BLA | Current |