Orange Book product
EXFORGE HCT EQ 10MG BASE;12.5MG;160MG
Orange Book NDA 022314 · NOVARTIS PHARMACEUTICALS CORP · Prescription
Key facts
| Proprietary name | EXFORGE HCT |
|---|---|
| Active ingredients | AMLODIPINE BESYLATE, HYDROCHLOROTHIAZIDE, VALSARTAN |
| Strength | EQ 10MG BASE;12.5MG;160MG |
| Dosage form | TABLET |
| Route | ORAL |
| Application | NDA022314 |
| Applicant holder | NOVARTIS PHARMACEUTICALS CORP |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | Yes |
| Reference standard (RS) | No |
| Approval date | Apr 30, 2009 |
At a glance
- 1–9 Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- Yes 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.