Orange Book product
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG
Orange Book ANDA 091431 · HERITAGE PHARMACEUTICALS INC DBA AVET PHARMACEUTICALS INC · Prescription
Key facts
| Proprietary name | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE |
|---|---|
| Active ingredients | AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDE |
| Strength | EQ 5MG BASE;40MG |
| Dosage form | CAPSULE |
| Route | ORAL |
| Application | ANDA091431 |
| Applicant holder | HERITAGE PHARMACEUTICALS INC DBA AVET PHARMACEUTICALS INC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Dec 30, 2013 |
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.