Drug application
LORATADINE AND PSEUDOEPHEDRINE SULFATE (LORATADINE, PSEUDOEPHEDRINE SULFATE)
Drugs@FDA ANDA 076557 · SUN PHARM INDS LTD
Key facts
| Drug name | LORATADINE AND PSEUDOEPHEDRINE SULFATE |
|---|---|
| Active ingredients | LORATADINE, PSEUDOEPHEDRINE SULFATE |
| Application type | ANDA |
| Application number | 076557 |
| Company | SUN PHARM INDS LTD |
| Dosage forms | TABLET, EXTENDED RELEASE, ORAL |
| Strength | 10MG;240MG |
| Marketing status | Over-the-counter |
| Reference listed drug | No |
| Latest submission status date | Sep 22, 2004 |
At a glance
- 1–9 Submissions
- 1–9 Supplements
- None Label versions
- 1–9 Products
- None Therapeutic equivalents
- No 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: