Drug application
AMBRISENTAN (AMBRISENTAN)
Drugs@FDA ANDA 209509 · PH HEALTH
Key facts
| Drug name | AMBRISENTAN |
|---|---|
| Active ingredients | AMBRISENTAN |
| Application type | ANDA |
| Application number | 209509 |
| Company | PH HEALTH |
| Dosage forms | TABLET, ORAL |
| Strength | 5MG |
| Marketing status | Discontinued |
| TE codes | AB |
| Reference listed drug | No |
| Latest submission status date | Apr 10, 2019 |
At a glance
- 1–9 Submissions
- 1–9 Supplements
- None Label versions
- 1–9 Products
- 10–99 Therapeutic equivalents
- No FDA letters on file
- No 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: