Application 019676
- Type
- BLA
- Sponsor
- GENENTECH
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NUTROPIN | SOMATROPIN [rDNA origin] | Injectable; Injection | N/A | No | No |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 66464 | SUPPL | 2021-03-03 |
| 66406 | APPL | 2020-03-23 |
| 46179 | SUPPL | 2020-03-23 |
| 46150 | SUPPL | 2020-03-23 |
| 44444 | SUPPL | 2020-03-23 |
| 44443 | SUPPL | 2020-03-23 |
| 44442 | SUPPL | 2020-03-23 |
| 40972 | SUPPL | 2020-03-23 |
| 40971 | SUPPL | 2020-03-23 |
| 33855 | SUPPL | 2020-03-23 |
| 33854 | SUPPL | 2020-03-23 |
| 33853 | SUPPL | 2020-03-23 |
| 33852 | SUPPL | 2020-03-23 |
| 33851 | SUPPL | 2020-03-23 |
| 23964 | SUPPL | 2020-03-23 |
| 19085 | SUPPL | 2020-03-23 |
| 19084 | SUPPL | 2020-03-23 |
| 19083 | SUPPL | 2020-03-23 |
| 19082 | SUPPL | 2020-03-23 |
| 11623 | SUPPL | 2020-03-23 |
| 1491 | SUPPL | 2020-03-23 |
| 1490 | SUPPL | 2020-03-23 |
| 1489 | SUPPL | 2020-03-23 |