Orange Book product
LORATADINE 10MG
Orange Book ANDA 075822 · GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS US LLC · Discontinued
Key facts
| Proprietary name | LORATADINE |
|---|---|
| Active ingredients | LORATADINE |
| Strength | 10MG |
| Dosage form | TABLET, ORALLY DISINTEGRATING |
| Route | ORAL |
| Application | ANDA075822 |
| Applicant holder | GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS US LLC |
| Marketing status | Discontinued |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Feb 10, 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.