Orange Book product
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 10MG BASE
Orange Book ANDA 207762 · APDM PHARMACEUTICALS PRIVATE LTD · Prescription
Key facts
| Proprietary name | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM |
|---|---|
| Active ingredients | AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM |
| Strength | EQ 5MG BASE;EQ 10MG BASE |
| Dosage form | TABLET |
| Route | ORAL |
| Application | ANDA207762 |
| Applicant holder | APDM PHARMACEUTICALS PRIVATE LTD |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Jan 11, 2019 |
At a glance
- 1–9 Marketed products with the same ingredient, strength and form
- 10–99 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.