Orange Book product
PENTAMIDINE ISETHIONATE 300MG/VIAL
Orange Book ANDA 206666 · PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC AND DBA PAI PHARMA · Prescription
Key facts
| Proprietary name | PENTAMIDINE ISETHIONATE |
|---|---|
| Active ingredients | PENTAMIDINE ISETHIONATE |
| Strength | 300MG/VIAL |
| Dosage form | INJECTABLE |
| Route | INJECTION |
| Application | ANDA206666 |
| Applicant holder | PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC AND DBA PAI PHARMA |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AP |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Sep 28, 2017 |
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.