Orange Book product
ALENDRONATE SODIUM EQ 70MG BASE/75ML
Orange Book ANDA 090520 · HIKMA PHARMACEUTICALS USA INC · Prescription
Key facts
| Proprietary name | ALENDRONATE SODIUM |
|---|---|
| Active ingredients | ALENDRONATE SODIUM |
| Strength | EQ 70MG BASE/75ML |
| Dosage form | SOLUTION |
| Route | ORAL |
| Application | ANDA090520 |
| Applicant holder | HIKMA PHARMACEUTICALS USA INC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AA |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | Yes |
| Approval date | Feb 25, 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.