Orange Book product
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 40MG BASE
Orange Book ANDA 205199 · APOTEX INC · Prescription
Key facts
| Proprietary name | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM |
|---|---|
| Active ingredients | AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM |
| Strength | EQ 10MG BASE;EQ 40MG BASE |
| Dosage form | TABLET |
| Route | ORAL |
| Application | ANDA205199 |
| Applicant holder | APOTEX INC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Nov 18, 2019 |
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.