Orange Book product
AMIKACIN SULFATE EQ 50MG BASE/ML
Orange Book ANDA 063313 · HIKMA PHARMACEUTICALS USA INC · Prescription
Key facts
| Proprietary name | AMIKACIN SULFATE |
|---|---|
| Active ingredients | AMIKACIN SULFATE |
| Strength | EQ 50MG BASE/ML |
| Dosage form | INJECTABLE |
| Route | INJECTION |
| Application | ANDA063313 |
| Applicant holder | HIKMA PHARMACEUTICALS USA INC |
| Marketing status | Prescription |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | Yes |
| Approval date | Apr 11, 1994 |
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.