Orange Book product
AMLODIPINE BESYLATE EQ 5MG BASE
Orange Book ANDA 076846 · TEVA PHARMACEUTICALS USA INC · Prescription
Key facts
| Proprietary name | AMLODIPINE BESYLATE |
|---|---|
| Active ingredients | AMLODIPINE BESYLATE |
| Strength | EQ 5MG BASE |
| Dosage form | TABLET |
| Route | ORAL |
| Application | ANDA076846 |
| Applicant holder | TEVA PHARMACEUTICALS USA INC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Jun 28, 2007 |
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.