Orange Book product
AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL
Orange Book ANDA 065403 · ACS DOBFAR SPA · Prescription
Key facts
| Proprietary name | AMPICILLIN AND SULBACTAM |
|---|---|
| Active ingredients | AMPICILLIN SODIUM, SULBACTAM SODIUM |
| Strength | EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL |
| Dosage form | INJECTABLE |
| Route | INJECTION |
| Application | ANDA065403 |
| Applicant holder | ACS DOBFAR SPA |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AP |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Dec 23, 2009 |
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.