FDA approval · Drugs@FDA
HUMULIN R PENinsulin recombinant human, insulin human
BLA018780 ·
FDA approved the original biologics license application for HUMULIN R PEN on October 28, 1982, sponsored by LILLY. FDA has approved 2 efficacy supplements on the application since, the most recent on March 25, 2011.
- Application
- BLA018780
- Sponsor
- LILLY
- Original approval
- Review
- standard review
- Submission class
- Type 1 - New Molecular Entity
- Active ingredient
- insulin recombinant human, insulin human
Browse every approval whose brand starts with H, or the complete response letters FDA has published — the applications it did not approve.
Products under this application
| Ingredient and strength | Form | Route | Marketing status |
|---|---|---|---|
| insulin recombinant human 100 UNITS/ML | INJECTABLE | INJECTION | Over-the-counter |
| insulin recombinant human 100 UNITS/ML | INJECTABLE | INJECTION | Over-the-counter |
| insulin human 10000 UNITS/20ML (500 UNITS/ML) | SOLUTION | SUBCUTANEOUS | Prescription |
| insulin human 1500 UNITS/3ML (500 UNITS/ML) | SOLUTION | SUBCUTANEOUS | Prescription |
Approved efficacy supplements
An efficacy supplement is how a sponsor asks FDA to approve a change that needs clinical evidence — most often a new indication. FDA’s record gives each one a submission number, a date and a review priority. It does not say what any supplement approved, so neither does this page. The approval letter and label for each are on accessdata.fda.gov under the application number.
| Approved | Supplement | Review |
|---|---|---|
| S-42 | — | |
| S-120 | standard |
FDA records other approved supplements on this application, by the class code it assigns them: Manufacturing (CMC) 63 · Labeling 36. Those are changes to the label or to how the drug is made rather than new clinical evidence, so they are counted here and not listed.
Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-03). Every field on this page comes from that record.
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