Orange Book product
NYSTATIN 100,000 UNITS/GM
Orange Book ANDA 212557 · TORRENT PHARMACEUTICALS LTD · Prescription
Key facts
| Proprietary name | NYSTATIN |
|---|---|
| Active ingredients | NYSTATIN |
| Strength | 100,000 UNITS/GM |
| Dosage form | CREAM |
| Route | TOPICAL |
| Application | ANDA212557 |
| Applicant holder | TORRENT PHARMACEUTICALS LTD |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AT |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Jul 24, 2019 |
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.