Orange Book product
LORATADINE AND PSEUDOEPHEDRINE SULFATE 5MG;120MG
Orange Book ANDA 076050 · PERRIGO PHARMA INTERNATIONAL DAC · Over the counter
Key facts
| Proprietary name | LORATADINE AND PSEUDOEPHEDRINE SULFATE |
|---|---|
| Active ingredients | LORATADINE, PSEUDOEPHEDRINE SULFATE |
| Strength | 5MG;120MG |
| Dosage form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Application | ANDA076050 |
| Applicant holder | PERRIGO PHARMA INTERNATIONAL DAC |
| Marketing status | Over the counter |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Jan 30, 2003 |
At a glance
- 1–9 Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- No Reference listed drug
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Orange Book products
The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.