Drug application
PREVACID NAPRAPAC 250 (COPACKAGED) (LANSOPRAZOLE, NAPROXEN)
Drugs@FDA NDA 021507 · TAKEDA PHARMS NA
Key facts
| Drug name | PREVACID NAPRAPAC 250 (COPACKAGED) |
|---|---|
| Active ingredients | LANSOPRAZOLE, NAPROXEN |
| Application type | NDA |
| Application number | 021507 |
| Company | TAKEDA PHARMS NA |
| Dosage forms | CAPSULE, DELAYED REL PELLETS, TABLET, ORAL |
| Strength | 15MG,N/A;N/A,250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |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 14, 2003 |
At a glance
- 1–9 Submissions
- 1–9 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: