Orange Book product
AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG
Orange Book ANDA 209591 · HETERO LABS LTD UNIT V · Prescription
Key facts
| Proprietary name | AMLODIPINE AND OLMESARTAN MEDOXOMIL |
|---|---|
| Active ingredients | AMLODIPINE BESYLATE, OLMESARTAN MEDOXOMIL |
| Strength | EQ 10MG BASE;40MG |
| Dosage form | TABLET |
| Route | ORAL |
| Application | ANDA209591 |
| Applicant holder | HETERO LABS LTD UNIT V |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Feb 14, 2025 |
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.