Drug application
DICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM, MISOPROSTOL)
Drugs@FDA ANDA 201089 · ACTAVIS LABS FL INC
Key facts
| Drug name | DICLOFENAC SODIUM AND MISOPROSTOL |
|---|---|
| Active ingredients | DICLOFENAC SODIUM, MISOPROSTOL |
| Application type | ANDA |
| Application number | 201089 |
| Company | ACTAVIS LABS FL INC |
| Dosage forms | TABLET, DELAYED RELEASE, ORAL |
| Strength | 50MG;0.2MG |
| Marketing status | Prescription |
| TE codes | AB |
| Reference listed drug | No |
| Latest submission class | Not Applicable |
| Latest submission status date | Jul 9, 2012 |
At a glance
- 1–9 Submissions
- 1–9 Supplements
- None Label versions
- 1–9 Products
- 1–9 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: