Drug application
BACLOFEN (BACLOFEN)
Drugs@FDA ANDA 209592 · PHARMOBEDIENT
Key facts
| Drug name | BACLOFEN |
|---|---|
| Active ingredients | BACLOFEN |
| Application type | ANDA |
| Application number | 209592 |
| Company | PHARMOBEDIENT |
| Dosage forms | INJECTABLE, INTRATHECAL |
| Strength | 0.5MG/ML |
| Marketing status | Discontinued |
| TE codes | AP |
| Reference listed drug | No |
| Latest submission status date | Mar 21, 2018 |
At a glance
- 1–9 Submissions
- 1–9 Label versions
- 1–9 Products
- 1–9 Therapeutic equivalents
- Yes 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: