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Application 020522
- Type
- BLA
- Sponsor
- GENENTECH
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | NUTROPIN AQ | SOMATROPIN | INJECTABLE;INJECTION | 10MG/2ML (5MG/ML) | No | No |
| 002 | NUTROPIN AQ PEN | SOMATROPIN | INJECTABLE;INJECTION | 10MG/2ML (5MG/ML) | No | No |
| 003 | NUTROPIN AQ NUSPIN | SOMATROPIN | INJECTABLE;INJECTION | 5MG/2ML (2.5MG/ML) | No | No |
| 004 | NUTROPIN AQ NUSPIN | SOMATROPIN | INJECTABLE;INJECTION | 20MG/2ML (10MG/ML) | No | No |
| 005 | NUTROPIN AQ NUSPIN | SOMATROPIN | INJECTABLE;INJECTION | 10MG/2ML (5MG/ML) | No | No |
| 006 | NUTROPIN AQ PEN | SOMATROPIN | INJECTABLE;INJECTION | 20MG/2ML (10MG/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50242-074 | Nutropin AQ NuSpin 10 | somatropin | Genentech, Inc. | BLA | Current |
| 50242-074 | Nutropin AQ NuSpin 10 | somatropin | Genentech, Inc. | BLA | Current |
| 50242-074 | Nutropin AQ NuSpin 10 | somatropin | Genentech, Inc. | BLA | Current |
| 50242-074 | Nutropin AQ NuSpin 10 | somatropin | Genentech, Inc. | BLA | Current |
| 50242-074 | Nutropin AQ NuSpin 10 | somatropin | Genentech, Inc. | BLA | Current |
| 50242-074 | Nutropin AQ NuSpin 10 | somatropin | Genentech, Inc. | NDA | Current |
| 50242-074 | Nutropin AQ NuSpin 10 | somatropin | Genentech, Inc. | NDA | Current |
| 50242-075 | Nutropin AQ NuSpin 5 | somatropin | Genentech, Inc. | BLA | Current |
| 50242-075 | Nutropin AQ NuSpin 5 | somatropin | Genentech, Inc. | BLA | Current |
| 50242-075 | Nutropin AQ NuSpin 5 | somatropin | Genentech, Inc. | BLA | Current |
| 50242-075 | Nutropin AQ NuSpin 5 | somatropin | Genentech, Inc. | BLA | Current |
| 50242-075 | Nutropin AQ NuSpin 5 | somatropin | Genentech, Inc. | BLA | Current |
| 50242-075 | Nutropin AQ NuSpin 5 | somatropin | Genentech, Inc. | NDA | Current |
| 50242-075 | Nutropin AQ NuSpin 5 | somatropin | Genentech, Inc. | NDA | Current |
| 50242-076 | Nutropin AQ NuSpin 20 | somatropin | Genentech, Inc. | NDA | Current |
| 50242-076 | Nutropin AQ NuSpin 20 | somatropin | Genentech, Inc. | NDA | Current |
| 50242-076 | Nutropin AQ NuSpin 20 | somatropin | Genentech, Inc. | BLA | Current |
| 50242-076 | Nutropin AQ NuSpin 20 | somatropin | Genentech, Inc. | BLA | Current |
| 50242-076 | Nutropin AQ NuSpin 20 | somatropin | Genentech, Inc. | BLA | Current |
| 50242-076 | Nutropin AQ NuSpin 20 | somatropin | Genentech, Inc. | BLA | Current |
| 50242-076 | Nutropin AQ NuSpin 20 | somatropin | Genentech, Inc. | BLA | Current |