Drug application
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE (GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE)
Drugs@FDA ANDA 091071 · ACTAVIS LABS FL
Key facts
| Drug name | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE |
|---|---|
| Active ingredients | GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE |
| Application type | ANDA |
| Application number | 091071 |
| Company | ACTAVIS LABS FL |
| Dosage forms | TABLET, EXTENDED RELEASE, ORAL |
| Strength | 600MG;60MG |
| Marketing status | Over-the-counter |
| Reference listed drug | No |
| Latest submission status date | May 27, 2015 |
At a glance
- 1–9 Submissions
- None Label versions
- 1–9 Products
- None 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: