Orange Book product
NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1%
Orange Book ANDA 207380 · PADAGIS ISRAEL PHARMACEUTICALS LTD · Prescription
Key facts
| Proprietary name | NYSTATIN AND TRIAMCINOLONE ACETONIDE |
|---|---|
| Active ingredients | NYSTATIN, TRIAMCINOLONE ACETONIDE |
| Strength | 100,000 UNITS/GM;0.1% |
| Dosage form | OINTMENT |
| Route | TOPICAL |
| Application | ANDA207380 |
| Applicant holder | PADAGIS ISRAEL PHARMACEUTICALS LTD |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AT |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Dec 20, 2016 |
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.