Drug application
ALEVE-D SINUS & COLD (NAPROXEN SODIUM, PSEUDOEPHEDRINE HYDROCHLORIDE)
Drugs@FDA NDA 021076 · BAYER
Key facts
| Drug name | ALEVE-D SINUS & COLD |
|---|---|
| Active ingredients | NAPROXEN SODIUM, PSEUDOEPHEDRINE HYDROCHLORIDE |
| Application type | NDA |
| Application number | 021076 |
| Company | BAYER |
| Dosage forms | TABLET, EXTENDED RELEASE, ORAL |
| Strength | 220MG;120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
| Marketing status | Discontinued |
| Reference listed drug | Yes |
| Latest submission class | Type 4 - New Combination |
| Latest submission status date | Nov 29, 1999 |
At a glance
- 1–9 Submissions
- 10–99 Supplements
- 1–9 Label versions
- 1–9 Products
- None 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: