Orange Book product
BACITRACIN ZINC AND POLYMYXIN B SULFATE 500 UNITS/GM;10,000 UNITS/GM
Orange Book ANDA 065022 · PADAGIS US LLC · Discontinued
Key facts
| Proprietary name | BACITRACIN ZINC AND POLYMYXIN B SULFATE |
|---|---|
| Active ingredients | BACITRACIN ZINC, POLYMYXIN B SULFATE |
| Strength | 500 UNITS/GM;10,000 UNITS/GM |
| Dosage form | OINTMENT |
| Route | OPHTHALMIC |
| Application | ANDA065022 |
| Applicant holder | PADAGIS US LLC |
| Marketing status | Discontinued |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Feb 27, 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.