Orange Book product
NYSTATIN 500,000 UNITS
Orange Book ANDA 062838 · SUN PHARMACEUTICAL INDUSTRIES INC · Discontinued
Key facts
| Proprietary name | NYSTATIN |
|---|---|
| Active ingredients | NYSTATIN |
| Strength | 500,000 UNITS |
| Dosage form | TABLET |
| Route | ORAL |
| Application | ANDA062838 |
| Applicant holder | SUN PHARMACEUTICAL INDUSTRIES INC |
| Marketing status | Discontinued |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Dec 22, 1988 |
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.