Drug application
APIDRA (INSULIN GLULISINE RECOMBINANT)
Drugs@FDA BLA 021629 · SANOFI AVENTIS US
Key facts
| Drug name | APIDRA |
|---|---|
| Active ingredients | INSULIN GLULISINE RECOMBINANT |
| Application type | BLA |
| Application number | 021629 |
| Company | SANOFI AVENTIS US |
| Dosage forms | INJECTABLE, INTRAVENOUS, SUBCUTANEOUS |
| Strength | 1000 UNITS/10ML (100 UNITS/ML) |
| Marketing status | Prescription |
| Reference listed drug | No |
| Latest submission class | Type 1 - New Molecular Entity |
| Latest submission status date | Apr 16, 2004 |
At a glance
- 1–9 Submissions
- 10–99 Supplements
- 10–99 Label versions
- 1–9 Products
- None Therapeutic equivalents
- Yes FDA letters on file
- Yes FDA reviews on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date: