Orange Book product
AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
Orange Book ANDA 065074 · HIKMA PHARMACEUTICALS USA INC · Discontinued
Key facts
| Proprietary name | AMPICILLIN AND SULBACTAM |
|---|---|
| Active ingredients | AMPICILLIN SODIUM, SULBACTAM SODIUM |
| Strength | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL |
| Dosage form | INJECTABLE |
| Route | INJECTION |
| Application | ANDA065074 |
| Applicant holder | HIKMA PHARMACEUTICALS USA INC |
| Marketing status | Discontinued |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Mar 19, 2002 |
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.