Orange Book product
LORATADINE 10MG
Orange Book ANDA 076134 · SUN PHARMACEUTICAL INDUSTRIES LTD · Over the counter
Key facts
| Proprietary name | LORATADINE |
|---|---|
| Active ingredients | LORATADINE |
| Strength | 10MG |
| Dosage form | TABLET |
| Route | ORAL |
| Application | ANDA076134 |
| Applicant holder | SUN PHARMACEUTICAL INDUSTRIES LTD |
| Marketing status | Over the counter |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Aug 18, 2003 |
At a glance
- 10–99 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.