Drug application
FULVESTRANT (FULVESTRANT)
Drugs@FDA NDA 210326 · FRESENIUS KABI USA
Key facts
| Drug name | FULVESTRANT |
|---|---|
| Active ingredients | FULVESTRANT |
| Application type | NDA |
| Application number | 210326 |
| Company | FRESENIUS KABI USA |
| Dosage forms | SOLUTION, INTRAMUSCULAR |
| Strength | 250MG/5ML (50MG/ML) |
| Marketing status | Prescription |
| TE codes | AO |
| Reference listed drug | No |
| Latest submission class | Type 5 - New Formulation or New Manufacturer |
| Latest submission status date | May 20, 2019 |
At a glance
- 1–9 Submissions
- 1–9 Supplements
- 1–9 Label versions
- 1–9 Products
- 10–99 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: