Orange Book product
POLYSPORIN 500 UNITS/GM;10,000 UNITS/GM **Federal Register…
Orange Book ANDA 061229 · MONARCH PHARMACEUTICALS INC · Discontinued
Key facts
| Proprietary name | POLYSPORIN |
|---|---|
| Active ingredients | BACITRACIN ZINC, POLYMYXIN B SULFATE |
| Strength | 500 UNITS/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons** |
| Dosage form | OINTMENT |
| Route | OPHTHALMIC |
| Application | ANDA061229 |
| Applicant holder | MONARCH PHARMACEUTICALS INC |
| Marketing status | Discontinued |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Jan 1, 1982 |
At a glance
- None 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.