Orange Book product
AMIKACIN SULFATE EQ 250MG BASE/ML
Orange Book ANDA 203323 · SAGENT PHARMACEUTICALS INC · Prescription
Key facts
| Proprietary name | AMIKACIN SULFATE |
|---|---|
| Active ingredients | AMIKACIN SULFATE |
| Strength | EQ 250MG BASE/ML |
| Dosage form | INJECTABLE |
| Route | INJECTION |
| Application | ANDA203323 |
| Applicant holder | SAGENT PHARMACEUTICALS INC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AP |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | May 12, 2016 |
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.