Application 018385
- Type
- NDA
- Sponsor
- NOVO NORDISK INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ULTRALENTE | INSULIN ZINC SUSP EXTENDED PURIFIED BEEF | INJECTABLE;INJECTION | 100 UNITS/ML | No | No |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N018385-001 | ULTRALENTE | 100 UNITS/ML | INJECTABLE / INJECTION | Approved before 1982 | 74a2ff9319b5… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N018385-001 | ULTRALENTE | 100 UNITS/ML | INJECTABLE / INJECTION | Approved before 1982 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N018385-001 | ULTRALENTE | 100 UNITS/ML | INJECTABLE / INJECTION | Approved before 1982 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N018385-001 | ULTRALENTE | 100 UNITS/ML | INJECTABLE / INJECTION | Approved before 1982 | ea99ee380514… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.