Orange Book product
AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;160MG
Orange Book ANDA 205137 · HETERO LABS LTD · Prescription
Key facts
| Proprietary name | AMLODIPINE BESYLATE AND VALSARTAN |
|---|---|
| Active ingredients | AMLODIPINE BESYLATE, VALSARTAN |
| Strength | EQ 5MG BASE;160MG |
| Dosage form | TABLET |
| Route | ORAL |
| Application | ANDA205137 |
| Applicant holder | HETERO LABS LTD |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Sep 16, 2016 |
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.