Orange Book product
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE 10,000 UNITS/ML;EQ 1MG BASE/ML
Orange Book ANDA 064211 · SANDOZ INC · Prescription
Key facts
| Proprietary name | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE |
|---|---|
| Active ingredients | POLYMYXIN B SULFATE, TRIMETHOPRIM SULFATE |
| Strength | 10,000 UNITS/ML;EQ 1MG BASE/ML |
| Dosage form | SOLUTION/DROPS |
| Route | OPHTHALMIC |
| Application | ANDA064211 |
| Applicant holder | SANDOZ INC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AT |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | Yes |
| Approval date | Apr 13, 1998 |
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.